Teste Nevalidate Oms

Disclaimer: WHO does not endorse any of the lists provided by NRAs.
This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.
Country Product name Manufacturer/applicant Link

of name
approval
United CDC 2019-nCoV Real- Centers for Disease For updated information on all products listed by the FDA use this link:
States Time RT-PCR Control and https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Diagnostic Panel Prevention's (CDC) authorizations-medical-devices/vitro-diagnostics-euas
(CDC)
United New York SARS-CoV- Wadsworth Center, New For updated information on all products listed by the FDA use this link:
States 2 Real-time Reverse York State Department https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Transcriptase (RT)- of Public Health's (CDC) authorizations-medical-devices/vitro-diagnostics-euas
PCR Diagnostic Panel
United cobas SARS-CoV-2 Roche Molecular For updated information on all products listed by the FDA use this link:
States Systems, Inc. (RMS) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/vitro-diagnostics-euas
United TaqPath COVID-19 Thermo Fisher Scientific, For updated information on all products listed by the FDA use this link:
States Combo Kit Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United COVID-19 RT-PCR Laboratory Corporation For updated information on all products listed by the FDA use this link:
States Test of America (LabCorp) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Panther Fusion SARS- Hologic, Inc. For updated information on all products listed by the FDA use this link:
States CoV-2 Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Quest SARS-CoV-2 Quest Diagnostics For updated information on all products listed by the FDA use this link:
States rRT-PCR Infectious Disease, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
1
V18 This list was compiled on 25 March and was last updated on 7 September 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
United Lyra SARS-CoV-2 Quidel Corporation For updated information on all products listed by the FDA use this link:
States Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Abbott RealTime Abbott Molecular For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United ePlex SARS-CoV-2 GenMark Diagnostics, For updated information on all products listed by the FDA use this link:
States Test Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Simplexa COVID-19 DiaSorin Molecular LLC For updated information on all products listed by the FDA use this link:
States Direct assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Xpert Xpress SARS- Cepheid For updated information on all products listed by the FDA use this link:
States CoV-2 test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Primerdesign Ltd Primerdesign Ltd. For updated information on all products listed by the FDA use this link:
States COVID-19 genesig https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Real-Time PCR assay authorizations-medical-devices/vitro-diagnostics-euas
United Accula SARS-Cov-2 Mesa Biotech Inc. For updated information on all products listed by the FDA use this link:
States Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BioFire COVID-19 BioFire Defense, LLC For updated information on all products listed by the FDA use this link:
2
United PerkinElmer New PerkinElmer, Inc. For updated information on all products listed by the FDA use this link:
States Coronavirus Nucleic https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Acid Detection Kit authorizations-medical-devices/vitro-diagnostics-euas
United AvellinoCoV2 test Avellino Lab USA, Inc. For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Real-Time BGI Genomics Co. Ltd For updated information on all products listed by the FDA use this link:
States Fluorescent RT-PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Kit for Detecting authorizations-medical-devices/vitro-diagnostics-euas
SARS-CoV-2
United NxTAG CoV Extended Luminex Molecular For updated information on all products listed by the FDA use this link:
States Panel Assay Diagnostics, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United ID NOW COVID-19 Abbott Diagnostics For updated information on all products listed by the FDA use this link:
States Scarborough, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United QIAstat-Dx QIAGEN GmbH For updated information on all products listed by the FDA use this link:
States Respiratory SARS- https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
CoV-2 Panel authorizations-medical-devices/vitro-diagnostics-euas
United NeuMoDx SARS-CoV- NeuMoDx Molecular, For updated information on all products listed by the FDA use this link:
States 2 Assay Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United COV-19 IDx assay Ipsum Diagnostics, LLC For updated information on all products listed by the FDA use this link:
3
United BioGX SARS-CoV-2 Becton, Dickinson & For updated information on all products listed by the FDA use this link:
States Reagents for BD MAX Company (BD) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
System authorizations-medical-devices/vitro-diagnostics-euas
United Logix Smart Co-Diagnostics, Inc. For updated information on all products listed by the FDA use this link:
States Coronavirus Disease https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
2019 (COVID-19) Kit authorizations-medical-devices/vitro-diagnostics-euas
United ScienCell SARS-CoV-2 ScienCell Research For updated information on all products listed by the FDA use this link:
States Coronavirus Real- Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
time RT-PCR (RT- authorizations-medical-devices/vitro-diagnostics-euas
qPCR) Detection Kit
United ARIES SARS-CoV-2 Luminex Corporation For updated information on all products listed by the FDA use this link:
United Gnomegen COVID-19 Gnomegen LLC For updated information on all products listed by the FDA use this link:
States RT-Digital PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Detection Kit authorizations-medical-devices/vitro-diagnostics-euas
United Smart Detect SARS- InBios International, Inc For updated information on all products listed by the FDA use this link:
States CoV-2 rRT-PCR Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United QuantiVirus SARS- DiaCarta, Inc For updated information on all products listed by the FDA use this link:
States CoV-2 Test kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BD SARS-CoV- Becton, Dickinson & For updated information on all products listed by the FDA use this link:
States 2Reagents for BD Company https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
MAX System authorizations-medical-devices/vitro-diagnostics-euas
4
United iAMP COVID-19 Atila BioSystems, Inc. For updated information on all products listed by the FDA use this link:
States Detection Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2 Maccura Biotechnology For updated information on all products listed by the FDA use this link:
States Fluorescent PCR Kit (USA) LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Curative-Korva SARS- KorvaLabs Inc. For updated information on all products listed by the FDA use this link:
States Cov-2 Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United GS"¢ COVID-19 RT- GenoSensor, LLC For updated information on all products listed by the FDA use this link:
States PCR KIT https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Fosun COVID-19 RT- Fosun Pharma USA Inc. For updated information on all products listed by the FDA use this link:
States PCR Detection Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United GeneFinder COVID- OSANG Healthcare For updated information on all products listed by the FDA use this link:
States 19 Plus RealAmp Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United PhoenixDx 2019-CoV Trax Management For updated information on all products listed by the FDA use this link:
States Services Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Allplex 2019-nCoV Seegene, Inc. For updated information on all products listed by the FDA use this link:
5
United RealStar SARS-CoV02 altona Diagnostics For updated information on all products listed by the FDA use this link:
States RT-PCR Kits U.S. GmbH https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United STANDARD M nCoV SD Biosensor, Inc. For updated information on all products listed by the FDA use this link:
States Real-Time Detection https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Kit authorizations-medical-devices/vitro-diagnostics-euas
United U-TOP COVID-19 SEASUN BIOMATERIALS For updated information on all products listed by the FDA use this link:
United LabGun COVID-19 RT- LabGenomics Co., Ltd. For updated information on all products listed by the FDA use this link:
States PCR Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Rheonix COVID-19 Rheonix, Inc. For updated information on all products listed by the FDA use this link:
States MDx Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Bio-Rad SARS-CoV-2 Bio-Rad Laboratories, For updated information on all products listed by the FDA use this link:
States ddPCR Test Inc https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BioFire Respiratory BioFire Diagnostics, LLC For updated information on all products listed by the FDA use this link:
States Panel 2.1 (RP2.1) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Novel Coronavirus Sansure BioTech Inc. For updated information on all products listed by the FDA use this link:
States (2019-nCoV) Nucleic https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Acid Diagnostic Kit authorizations-medical-devices/vitro-diagnostics-euas
(PCR-Fluorescence
Probing)
6
United FTD SARS-CoV-2 Fast Track Diagnostics For updated information on all products listed by the FDA use this link:
States Luxembourg S.á.r.l. (a https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Siemens Healthineers authorizations-medical-devices/vitro-diagnostics-euas
Company)
United OPTI SARS-CoV-2 RT OPTI Medical Systems, For updated information on all products listed by the FDA use this link:
States PCR Test Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Sherlock CRISPR Sherlock BioSciences, For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 Kit Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-COV-2 R-GENE BioMérieux SA For updated information on all products listed by the FDA use this link:
United Rutgers Clinical Rutgers Clinical For updated information on all products listed by the FDA use this link:
States Genomics Laboratory Genomics Laboratory at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
TaqPath SARS-CoV-2- RUCDR Infinite Biologics authorizations-medical-devices/vitro-diagnostics-euas
Assay - Rutgers University
United Quick SARS-CoV- Zymo Research For updated information on all products listed by the FDA use this link:
States 2rRT-PCR Kit Corporation https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Gnomegen COVID- Gnomegen LLC For updated information on all products listed by the FDA use this link:
States 19-RT-qPCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Detection Kit authorizations-medical-devices/vitro-diagnostics-euas
United 1copy COVID-19 1drop Inc. For updated information on all products listed by the FDA use this link:
States qPCR Multi Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
7
United Alinity m SARS-CoV-2 Abbott Molecular Inc. For updated information on all products listed by the FDA use this link:
States assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Linea COVID-19 Assay Applied DNA Sciences, For updated information on all products listed by the FDA use this link:
States Kit Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Aptima SARS-CoV-2 Hologic, Inc. For updated information on all products listed by the FDA use this link:
States assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United NeoPlex COVID-19 GeneMatrix, Inc. For updated information on all products listed by the FDA use this link:
United Fulgent COVID-19 by Fulgent Therapeutics, For updated information on all products listed by the FDA use this link:
States RT-PCR Test LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Everlywell COVID-19 Everlywell, Inc. For updated information on all products listed by the FDA use this link:
States Test Home Collection https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Assurance SARS-CoV- Assurance Scientific For updated information on all products listed by the FDA use this link:
States 2 Panel Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Lyra Direct SARS-CoV- Quidel Corporation For updated information on all products listed by the FDA use this link:
States 2 Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
8
United Color Genomics Color Genomics, Inc. For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 RT-LAMP https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Diagnostic Assay authorizations-medical-devices/vitro-diagnostics-euas
United P23 Labs TaqPath P23 Labs, LLC. For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United AQ-TOP COVID-19 Seasun Biomaterials, For updated information on all products listed by the FDA use this link:
States Rapid Detection Kit Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United DiaPlexQ Novel SolGent Co., Ltd For updated information on all products listed by the FDA use this link:
States Coronavirus (2019- https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
nCoV) Detection Kit authorizations-medical-devices/vitro-diagnostics-euas
United BioCore 2019-nCoV BioCore Co., Ltd. For updated information on all products listed by the FDA use this link:
States Real Time PCR Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Hymon SARS-CoV-2 dba SpectronRX For updated information on all products listed by the FDA use this link:
States Test Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2 (N gene Exact Sciences For updated information on all products listed by the FDA use this link:
States detection) Test Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United LetsGetChecked PrivaPath Diagnostics, For updated information on all products listed by the FDA use this link:
States Coronavirus (COVID- Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
19) Test authorizations-medical-devices/vitro-diagnostics-euas
9
United Gravity Diagnostics Gravity Diagnostics, LLC For updated information on all products listed by the FDA use this link:
States COVID-19 Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Phosphorus COVID- Phosphorus Diagnostics For updated information on all products listed by the FDA use this link:
States 19 RT-qPCR Test LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Genetron SARS-CoV- Genetron Health For updated information on all products listed by the FDA use this link:
States 2 RNA Test (Beijing) Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United EURORealTime SARS- Euroimmun US, Inc. For updated information on all products listed by the FDA use this link:
States Cov-2 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Illumina COVIDSeq Illumina, Inc. For updated information on all products listed by the FDA use this link:
United HDPCR SARS-CoV-2 ChromaCode Inc. For updated information on all products listed by the FDA use this link:
United DTPM COVID-19 RT- Tide Laboratories, LLC For updated information on all products listed by the FDA use this link:
States PCR Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United ExProbe SARS-CoV-2 TBG Biotechnology For updated information on all products listed by the FDA use this link:
States Testing Kit Corp. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
10
United Cue COVID-19 Test Cue Health Inc. For updated information on all products listed by the FDA use this link:
United Diagnovital SARS- RTA Laboratories For updated information on all products listed by the FDA use this link:
States CoV-2 Real-Time PCR Biological Products https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Kit Pharmaceutical and authorizations-medical-devices/vitro-diagnostics-euas
Machinery Industry
United KPMAS COVID-19 Kaiser Permanente Mid- For updated information on all products listed by the FDA use this link:
States Test Atlantic States https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BioCode SARS-CoV-2 Applied BioCode, Inc. For updated information on all products listed by the FDA use this link:
United OSUWMC COVID-19 The Ohio State For updated information on all products listed by the FDA use this link:
States RT-PCR test University Wexner https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Medical Center authorizations-medical-devices/vitro-diagnostics-euas
United Omni COVID-19 Omnipathology For updated information on all products listed by the FDA use this link:
States Assay by RT-PCR Solutions Medical https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Corporation authorizations-medical-devices/vitro-diagnostics-euas
United COVID-19 Jiangsu Bioperfectus For updated information on all products listed by the FDA use this link:
States Coronavirus Real Technologies Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Time PCR Kit authorizations-medical-devices/vitro-diagnostics-euas
United TRUPCR SARS-CoV-2 3B Blackbio Biotech For updated information on all products listed by the FDA use this link:
States Kit India Ltd., a subsidiary https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
of Kilpest India Ltd. authorizations-medical-devices/vitro-diagnostics-euas
11
United HealthQuest HealthQuest Esoterics For updated information on all products listed by the FDA use this link:
States Esoterics TaqPath https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
SARS-CoV-2 Assay authorizations-medical-devices/vitro-diagnostics-euas
United FRL SARS CoV-2 Test University of Alabama at For updated information on all products listed by the FDA use this link:
States Birmingham Fungal https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Reference Lab authorizations-medical-devices/vitro-diagnostics-euas
United GenePro SARS-CoV-2 Gencurix, Inc. For updated information on all products listed by the FDA use this link:
United MD Anderson High- University of Texas MD For updated information on all products listed by the FDA use this link:
States throughput SARS- Anderson Cancer https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
CoV-2 RT-PCR Assay Center, Molecular authorizations-medical-devices/vitro-diagnostics-euas
Diagnostics Laboratory
United DSL COVID-19 Assay Diagnostic Solutions For updated information on all products listed by the FDA use this link:
States Laboratory, LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United FastPlex Triplex SARS- PreciGenome LLC For updated information on all products listed by the FDA use this link:
States CoV-2 detection kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
(RT-Digital PCR) authorizations-medical-devices/vitro-diagnostics-euas
United IntelliPlex SARS-CoV- PlexBio Co., Ltd. For updated information on all products listed by the FDA use this link:
States 2 Detection Kit https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Inform Diagnostics Inform Diagnostics, Inc. For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 RT-PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Assay authorizations-medical-devices/vitro-diagnostics-euas
12
United LifeHope 2019-nCoV LifeHope Labs For updated information on all products listed by the FDA use this link:
States Real-Time RT-PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Diagnostic Panel authorizations-medical-devices/vitro-diagnostics-euas
United Acupath COVID-19 Acupath Laboratories, For updated information on all products listed by the FDA use this link:
States Real-Time (RT-PCR) Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Psoma COVID-19 RT Psomagen, Inc. For updated information on all products listed by the FDA use this link:
United COVID-19 RT-PCR TNS Co., Ltd (Bio TNS) For updated information on all products listed by the FDA use this link:
States Peptide Nucleic Acid https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
(PNA) kit authorizations-medical-devices/vitro-diagnostics-euas
United Kroger Health COVID- The Kroger Co. For updated information on all products listed by the FDA use this link:
States 19 Test Home https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Collection Kit authorizations-medical-devices/vitro-diagnostics-euas
United CentoFast-SARS-CoV- CENTOGENE US, LLC For updated information on all products listed by the FDA use this link:
States 2 RT-PCR Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Influenza SARS-CoV-2 Centers for Disease For updated information on all products listed by the FDA use this link:
States (Flu SC2) Multiplex Control and Prevention https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Assay (CDC) authorizations-medical-devices/vitro-diagnostics-euas
United Laboratorio Clinico Laboratorio Clinico For updated information on all products listed by the FDA use this link:
States Toledo SARS-CoV-2 Toledo https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
13
United AMPIPROBE SARS- Enzo Life Sciences, Inc. For updated information on all products listed by the FDA use this link:
States CoV-2 Test System https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United CareStart COVID-19 Access Bio, Inc. For updated information on all products listed by the FDA use this link:
States MDx RT-PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Gene By Gene SARS- Gene By Gene For updated information on all products listed by the FDA use this link:
States CoV-2 Detection Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United CRSP SARS-CoV-2 Clinical Research For updated information on all products listed by the FDA use this link:
States Real-time Reverse Sequencing Platform https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Transcriptase (RT)- (CRSP), LLC at the Broad authorizations-medical-devices/vitro-diagnostics-euas
PCR Diagnostic Assay Institute of MIT and
Harvard
United SARS-CoV-2 RNA UCSF Health Clinical For updated information on all products listed by the FDA use this link:
States DETECTR Assay Laboratories, UCSF https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Clinical Labs at China authorizations-medical-devices/vitro-diagnostics-euas
Basin
United Real-Q 2019-nCoV BioSewoom, Inc. For updated information on all products listed by the FDA use this link:
United BMC-CReM COVID-19 Boston Medical Center For updated information on all products listed by the FDA use this link:
United PowerChek 2019- KogeneBiotech Co., Ltd. For updated information on all products listed by the FDA use this link:
States nCoV Real-time PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
14
United PhoenixDx SARS-CoV- Trax Management For updated information on all products listed by the FDA use this link:
States 2 Multiplex Services Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Compass Laboratory Compass Laboratory For updated information on all products listed by the FDA use this link:
States Services SARS-CoV2 Services, LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Quest Diagnostics PF Quest Diagnostics For updated information on all products listed by the FDA use this link:
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United Quest Diagnostics RC Quest Diagnostics For updated information on all products listed by the FDA use this link:
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United OraRisk COVID-19 RT- Access Genetics, LLC For updated information on all products listed by the FDA use this link:
States PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United QuantiVirus SARS- DiaCarta, Inc. For updated information on all products listed by the FDA use this link:
States CoV-2 Multiplex Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
15
United Helix COVID-19 Test Helix OpCo LLC (dba For updated information on all products listed by the FDA use this link:
States Helix) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Novel Coronavirus Jiangsu CoWin Biotech For updated information on all products listed by the FDA use this link:
States (SARS-CoV-2) Fast Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Nucleic Acid authorizations-medical-devices/vitro-diagnostics-euas
Detection Kit (PCR-
Fluorescence
Probing)
United Lilly SARS-CoV-2 Eli Lilly and Company For updated information on all products listed by the FDA use this link:
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United CRL Rapid Response Clinical Reference For updated information on all products listed by the FDA use this link:
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United UCSD RC SARS-CoV-2 University of California For updated information on all products listed by the FDA use this link:
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United Wren Laboratories Wren Laboratories LLC For updated information on all products listed by the FDA use this link:
States COVID-19 PCR Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
16
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States SARS-CoV-2 MALDI- https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
TOF Assay authorizations-medical-devices/vitro-diagnostics-euas
United Cleveland Clinic Cleveland Clinic Robert For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 Assay J. Tomsich Pathology https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
and Laboratory authorizations-medical-devices/vitro-diagnostics-euas
Medicine Institute
United Poplar SARS-CoV-2 Poplar Healthcare For updated information on all products listed by the FDA use this link:
States TMA Pooling assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Genus SARS-CoV-2 ISPM Labs, LLC dba For updated information on all products listed by the FDA use this link:
States Assay Capstone Healthcare https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United ViroKey SARS-CoV-2 Vela Operations For updated information on all products listed by the FDA use this link:
States RT-PCR Test Singapore Pte Ltd https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Helix COVID-19 NGS Helix OpCo LLC (dba For updated information on all products listed by the FDA use this link:
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United GWU SARS-CoV-2 RT- George Washington For updated information on all products listed by the FDA use this link:
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United Solaris Multiplex Solaris Diagnostics For updated information on all products listed by the FDA use this link:
17
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States TaqPath SARS-CoV-2 Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Combo Assay authorizations-medical-devices/vitro-diagnostics-euas
United Biomeme SARS-CoV- Biomeme, Inc. For updated information on all products listed by the FDA use this link:
States 2 Real-Time RT-PCR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Test authorizations-medical-devices/vitro-diagnostics-euas
United LumiraDx SARS-CoV-2 LumiraDx UK Ltd. For updated information on all products listed by the FDA use this link:
States RNA STAR https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Pro-AmpRT SARS- Pro-Lab Diagnostics For updated information on all products listed by the FDA use this link:
States CoV-2 Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SalivaDirect Yale School of Public For updated information on all products listed by the FDA use this link:
States Health, Department of https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Epidemiology of authorizations-medical-devices/vitro-diagnostics-euas
Microbial Diseases
United COVID-19 Nucleic ZhuHai Sinochips For updated information on all products listed by the FDA use this link:
States Acid RT-PCR Test Kit Bioscience Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Guardant-19 Guardant Health, Inc. For updated information on all products listed by the FDA use this link:
United DxTerity SARS-CoV-2 DxTerity Diagnostics, For updated information on all products listed by the FDA use this link:
States RT-PCR Test Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
18
United Texas Department of Texas Department of For updated information on all products listed by the FDA use this link:
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(DSHS) SARS-CoV-2 Laboratory Services authorizations-medical-devices/vitro-diagnostics-euas
Assay Section
United Advanta Dx SARS- Fluidigm Corporation For updated information on all products listed by the FDA use this link:
States CoV-2 RT-PCR Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United QDX SARS-CoV-2 QDx Pathology Services For updated information on all products listed by the FDA use this link:
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States SARS-CoV-2 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Molecular Assay authorizations-medical-devices/vitro-diagnostics-euas
United PCL SARS-CoV-2 Real- Patients Choice For updated information on all products listed by the FDA use this link:
States Time RT-PCR Assay Laboratories, LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United DxTerity SARS-CoV-2 DxTerity Diagnostics, For updated information on all products listed by the FDA use this link:
States RT PCR CE Test Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United T2SARS-CoV-2 Panel T2 Biosystems, Inc. For updated information on all products listed by the FDA use this link:
United MiraDx SARS-CoV-2 MiraDx For updated information on all products listed by the FDA use this link:
States RT-PCR assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
19
United SARS-CoV-2 DETECTR Mammoth Biosciences, For updated information on all products listed by the FDA use this link:
States Reagent Kit Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BayCare SARS-CoV-2 BayCare Laboratories, For updated information on all products listed by the FDA use this link:
States RT PCR Assay LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Color COVID-19 Test Color Genomics, Inc. For updated information on all products listed by the FDA use this link:
States Unmonitored https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Collection Kit authorizations-medical-devices/vitro-diagnostics-euas
United MobileDetect Bio Detectachem Inc. For updated information on all products listed by the FDA use this link:
States BCC19 (MD-Bio https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
BCC19) Test Kit authorizations-medical-devices/vitro-diagnostics-euas
United Kaira 2019-nCoV OPTOLANE For updated information on all products listed by the FDA use this link:
States Detection Kit Technologies, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Bio-Speedy Direct RT- Bioeksen R&D For updated information on all products listed by the FDA use this link:
States qPCR SARS-CoV-2 Technologies Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United cobas SARS-CoV-2 & Roche Molecular For updated information on all products listed by the FDA use this link:
States Influenza A/B Systems, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Cormeum SARS-CoV- Cormeum Laboratory For updated information on all products listed by the FDA use this link:
States 2 Assay Services https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
20
United Warrior Diagnostics Warrior Diagnostics, Inc. For updated information on all products listed by the FDA use this link:
United NEcov19 RT-PCR Nebraska Medicine For updated information on all products listed by the FDA use this link:
States Assay Clinical Laboratory https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Aspirus SARS-CoV rRT Aspirus Reference For updated information on all products listed by the FDA use this link:
States Assay Laboratory https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United CSI SARS-CoV-2 RT CSI Laboratories For updated information on all products listed by the FDA use this link:
States PCR Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Express Gene 2019- Express Gene LLC (dba For updated information on all products listed by the FDA use this link:
States nCoV RT-PCR Molecular Diagnostics https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Diagnostic Panel Laboratory) authorizations-medical-devices/vitro-diagnostics-euas
United Avera Institute for Avera Institute for For updated information on all products listed by the FDA use this link:
States Human Genetics Human Genetics https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
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United SARS-CoV-2 Real- One Health For updated information on all products listed by the FDA use this link:
States Time RT-PCR-Test Laboratories, LLC https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2-Assay Cedars-Sinai Medical For updated information on all products listed by the FDA use this link:
States Center, Department of https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Pathology and authorizations-medical-devices/vitro-diagnostics-euas
Laboratory Medicine
21
United TRIPLEX CII-SARS- Columbia University For updated information on all products listed by the FDA use this link:
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Personalized Genomic authorizations-medical-devices/vitro-diagnostics-euas
Medicine
United Biocollections Biocollections For updated information on all products listed by the FDA use this link:
States Worldwide SARS-Co- Worldwide, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
V-2 Assay authorizations-medical-devices/vitro-diagnostics-euas
United UTHSC/UCH SARS- UTMG Pathology For updated information on all products listed by the FDA use this link:
States CoV-2-RT-PCR Assay Laboratory https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Altru Dx SARS-CoV-2 Altru Diagnostics, Inc. For updated information on all products listed by the FDA use this link:
States RT-PCR assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2 Test Biocerna For updated information on all products listed by the FDA use this link:
United SARS-CoV-2 Assay Nationwide Children's For updated information on all products listed by the FDA use this link:
States Hospital https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United UDX SARS-CoV-2 Ultimate Dx Laboratory For updated information on all products listed by the FDA use this link:
States Molecular Assay https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2 Assay AIT Laboratories For updated information on all products listed by the FDA use this link:
22
United COVID-19 Key Southwest Regional PCR For updated information on all products listed by the FDA use this link:
States Laboratory LLC. dba https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
MicroGen DX authorizations-medical-devices/vitro-diagnostics-euas
United SARS-CoV-2 PCR Test Diatherix Eurofins For updated information on all products listed by the FDA use this link:
States Laboratory https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2 Mayo Clinic For updated information on all products listed by the FDA use this link:
States Molecular Detection Laboratories, Rochester, https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Assay MN authorizations-medical-devices/vitro-diagnostics-euas
United CDI Enhanced COVID- Hackensack University For updated information on all products listed by the FDA use this link:
States 19 Test Medical Center (HUMC) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
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Laboratory
United CirrusDx SARS-CoV-2 CirrusDx Laboratories For updated information on all products listed by the FDA use this link:
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(IDDL), Boston authorizations-medical-devices/vitro-diagnostics-euas
Children's Hospital
United SARS-CoV-2 Test Exact Sciences For updated information on all products listed by the FDA use this link:
States Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
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23
United COVID-19 RT-PCR Pathology/Laboratory For updated information on all products listed by the FDA use this link:
States Test Medicine Lab of Baptist https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Hospital Miami authorizations-medical-devices/vitro-diagnostics-euas
United Orig3n 2019 Novel Orig3n, Inc. For updated information on all products listed by the FDA use this link:
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19) Test authorizations-medical-devices/vitro-diagnostics-euas
United SDI SARS-CoV-2 Assay Specialty Diagnostic For updated information on all products listed by the FDA use this link:
States (SDI) Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United UNC Health SARS- University of North For updated information on all products listed by the FDA use this link:
States CoV-2 real-time RT- Carolina Medical Center https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
PCR test authorizations-medical-devices/vitro-diagnostics-euas
United Stanford SARS-CoV-2 Stanford Health Care For updated information on all products listed by the FDA use this link:
States assay Clinical Virology https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Laboratory authorizations-medical-devices/vitro-diagnostics-euas
United Viracor SARS-CoV-2 Viracor Eurofins Clinical For updated information on all products listed by the FDA use this link:
States assay Diagnostics https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United MGH COVID-19 qPCR Massachusetts General For updated information on all products listed by the FDA use this link:
States assay Hospital https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-Cov-2 Assay Diagnostic Molecular For updated information on all products listed by the FDA use this link:
States Laboratory - https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Northwestern Medicine authorizations-medical-devices/vitro-diagnostics-euas
24
United SARS-CoV-2 RT-PCR Infectious Disease For updated information on all products listed by the FDA use this link:
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Children's Hospital of authorizations-medical-devices/vitro-diagnostics-euas
Philadelphia
United SARS-CoV-2 PCR test Yale New Haven For updated information on all products listed by the FDA use this link:
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Virology Laboratory authorizations-medical-devices/vitro-diagnostics-euas
United BinaxNOW COVID-19 Abbott Diagnostics For updated information on all products listed by the FDA use this link:
States Ag Card Scarborough, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United LumiraDx SARS-CoV-2 LumiraDx UK Ltd. For updated information on all products listed by the FDA use this link:
States Ag Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BD Veritor System for Becton, Dickinson and For updated information on all products listed by the FDA use this link:
States Rapid Detection of Company (BD) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
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United Sofia SARS Antigen Quidel Corporation For updated information on all products listed by the FDA use this link:
States FIA https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SGTi-flex COVID-19 Sugentech, Inc. For updated information on all products listed by the FDA use this link:
States IgG https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United TBG SARS-CoV-2 IgG / TBG Biotechnology For updated information on all products listed by the FDA use this link:
States IgM Rapid Test Kit Corp. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
25
United COVID-19 ELISA pan- University of Arizona For updated information on all products listed by the FDA use this link:
States Ig Antibody Test Genetics Core for https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Clinical Services authorizations-medical-devices/vitro-diagnostics-euas
United Tell Me Fast Novel Biocan Diagnostics Inc. For updated information on all products listed by the FDA use this link:
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19) IgG/IgM Antibody authorizations-medical-devices/vitro-diagnostics-euas
Test - Letter of
Authorization
United BioCheck SARS-CoV-2 BioCheck, Inc. For updated information on all products listed by the FDA use this link:
States IgG and IgM Combo https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Test authorizations-medical-devices/vitro-diagnostics-euas
United Diazyme DZ-Lite Diazyme Laboratories, For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 IgM CLIA Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United VIDAS SARS-CoV-2 bioMérieux SA For updated information on all products listed by the FDA use this link:
States IgM https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
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United WANTAI SARS-CoV-2 Beijing Wantai Biological For updated information on all products listed by the FDA use this link:
States Ab ELISA Pharmacy Enterprise https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Co., Ltd. authorizations-medical-devices/vitro-diagnostics-euas
United Atellica IM SARS-CoV- Siemens Healthcare For updated information on all products listed by the FDA use this link:
States 2 IgG (COV2G) Diagnostics Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
26
United ADVIA Centaur SARS- Siemens Healthcare For updated information on all products listed by the FDA use this link:
States CoV-2 IgG (COV2G) Diagnostics Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United BIOTIME SARS-CoV-2 Xiamen Biotime For updated information on all products listed by the FDA use this link:
States IgG/IgM Rapid Biotechnology Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Qualitative Test authorizations-medical-devices/vitro-diagnostics-euas
United CareStart COVID-19 Access Bio, Inc. For updated information on all products listed by the FDA use this link:
States IgM/IgG https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Rapid COVID-19 Megna Health, Inc. For updated information on all products listed by the FDA use this link:
States IgM/IgG Combo Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United xMAP SARS-CoV-2 Luminex Corporation For updated information on all products listed by the FDA use this link:
States Multi-Antigen IgG https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Sienna-Clarity Salofa Oy For updated information on all products listed by the FDA use this link:
States COVIBLOCK COVID-19 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
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Cassette
United WANTAI SARS-CoV-2 Beijing Wantai Biological For updated information on all products listed by the FDA use this link:
States Ab Rapid Test Pharmacy Enterprise https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Co., Ltd. authorizations-medical-devices/vitro-diagnostics-euas
United Diazyme DZ-Lite Diazyme Laboratories, For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 IgG CLIA Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
27
United Assure COVID-19 Assure Tech. (Hangzhou For updated information on all products listed by the FDA use this link:
States IgG/IgM Rapid Test Co., Ltd) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Device authorizations-medical-devices/vitro-diagnostics-euas
United SCoV-2 Detect IgM InBios International, Inc. For updated information on all products listed by the FDA use this link:
States ELISA https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Access SARS-CoV-2 Beckman Coulter, Inc. For updated information on all products listed by the FDA use this link:
United Babson Diagnostics Babson Diagnostics, Inc. For updated information on all products listed by the FDA use this link:
States aC19G1 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United LYHER Novel Hangzhou Laihe Biotech For updated information on all products listed by the FDA use this link:
States Coronavirus (2019- Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
nCoV) IgM/IgG authorizations-medical-devices/vitro-diagnostics-euas
Antibody Combo Test
Kit (Colloidal Gold)
United Biohit SARS-CoV-2 Biohit Healthcare (Hefei) For updated information on all products listed by the FDA use this link:
States IgM/IgG Antibody Co. Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Test Kit authorizations-medical-devices/vitro-diagnostics-euas
United SARS-CoV-2 RBD IgG Emory Medical For updated information on all products listed by the FDA use this link:
States test Laboratories https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SCoV-2 Detect IgG InBios International, Inc. For updated information on all products listed by the FDA use this link:
States ELISA https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
28
United Dimension Vista Siemens Healthcare For updated information on all products listed by the FDA use this link:
States SARS-CoV-2 Total Diagnostics Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
antibody assay authorizations-medical-devices/vitro-diagnostics-euas
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United Dimension EXL SARS- Siemens Healthcare For updated information on all products listed by the FDA use this link:
States CoV-2 Total antibody Diagnostics Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
assay (CV2T) authorizations-medical-devices/vitro-diagnostics-euas
United Vibrant COVID-19 Ab Vibrant America Clinical For updated information on all products listed by the FDA use this link:
States Assay Labs https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United RightSign COVID-19 Hangzhou Biotest For updated information on all products listed by the FDA use this link:
States IgG/IgM Rapid Test Biotech Co., Ltd. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Cassette authorizations-medical-devices/vitro-diagnostics-euas
United COVID-19 IgG/IgM Healgen Scientific LLC For updated information on all products listed by the FDA use this link:
States Rapid Test Cassette https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
(Whole authorizations-medical-devices/vitro-diagnostics-euas
Blood/Serum/Plasma
)
United Atellica IM SARS-CoV- Siemens Healthcare For updated information on all products listed by the FDA use this link:
States 2 Total (COV2T) Diagnostics Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United ADVIA Centaur SARS- Siemens Healthcare For updated information on all products listed by the FDA use this link:
States CoV-2 Total (COV2T) Diagnostics Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Anti-SARS-CoV-2 EUROIMMUN US Inc. For updated information on all products listed by the FDA use this link:
States ELISA (IgG) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
29
United Elecsys Anti-SARS- Roche Diagnostics For updated information on all products listed by the FDA use this link:
States CoV-2 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United New York SARS-CoV Wadsworth Center, New For updated information on all products listed by the FDA use this link:
States Microsphere York State Department https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Immunoassay for of Health authorizations-medical-devices/vitro-diagnostics-euas
Antibody Detection
United Platelia SARS-CoV-2 Bio-Rad Laboratories, For updated information on all products listed by the FDA use this link:
States Total Ab assay Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United SARS-CoV-2 IgG assay Abbott Laboratories Inc. For updated information on all products listed by the FDA use this link:
United LIAISON SARS-CoV-2 DiaSorin Inc. For updated information on all products listed by the FDA use this link:
States S1/S2 IgG https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United VITROS Ortho-Clinical For updated information on all products listed by the FDA use this link:
States Immunodiagnostic Diagnostics, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Products Anti-SARS- authorizations-medical-devices/vitro-diagnostics-euas
CoV-2 IgG Reagent
Pack
United COVID-19 ELISA IgG Mount Sinai Laboratory For updated information on all products listed by the FDA use this link:
States Antibody Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United VITROS Ortho Clinical For updated information on all products listed by the FDA use this link:
States Immunodiagnostic Diagnostics, Inc. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Products Anti-SARS- authorizations-medical-devices/vitro-diagnostics-euas
30
CoV-2 Total Reagent

Pack
United qSARS-CoV-2 IgG/IgM Cellex Inc. For updated information on all products listed by the FDA use this link:
States Rapid Test https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
United Elecsys IL-6 Roche Diagnostics For updated information on all products listed by the FDA use this link:
For updated information on all products listed by Health Canada use this link:
Spartan Cube COVID- Spartan Bioscience Inc. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada
19 System (Canada) devices/covid-19/diagnostic-devices-authorized.html
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada cobas SARS-CoV-2 Roche (United States)
devices/covid-19/diagnostic-devices-authorized.html
Advia Centaur Sars- Siemens Healthcare
Canada Cov-2 Total (Cov2t) / Diagnostics Inc. (Unites
Advia Centaur Sars- States)
Aptima Sars-Cov-2 For updated information on all products listed by Health Canada use this link:
Assay Kit And https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Controls Kit, Aptima devices/covid-19/diagnostic-devices-authorized.html
Hologic, Inc. (United
Canada Multitest Swab
States)
Specimen Collection
Kit For Sars-Cov-2
Specimen Collection
Atellica Im Sars-Cov-2
Siemens Healthcare https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada Total (Cov2t) /
Diagnostics Inc. devices/covid-19/diagnostic-devices-authorized.html
Atellica Im Sars-Cov2-
31
Total Quality Control

(Cov2t Qc)
Sars-Cov-2 Virus Ningbo Health Gene
Canada Detection Diagnostic Technologies Co., Ltd
Kit (Rt-Qpcr Method) (China)
Fast Track Diagnostics For updated information on all products listed by Health Canada use this link:
Canada FTD SARS-COV-2 Luxembourg S.A.R.L. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(Luxembourg) devices/covid-19/diagnostic-devices-authorized.html
Diagnostic Hybrids, Inc. - For updated information on all products listed by Health Canada use this link:
Lyra Direct Sars-Cov-
Canada Also Trading as Quidel https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
2 Assay
Corporation devices/covid-19/diagnostic-devices-authorized.html
Biomeme SARS-CoV- For updated information on all products listed by Health Canada use this link:
2 Go-Strips for use https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Biomeme Inc. (United
Canada with Biomeme's devices/covid-19/diagnostic-devices-authorized.html
States)
Franklin Real-Time
PCR System
Aries SARS-CoV-2 Luminex Corporation
Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Assay (United States)
Abbott Laboratories For updated information on all products listed by Health Canada use this link:
SARS-CoV-2 IgG Assay
Canada Diagnostics Division https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(Alinity I)
(United States) devices/covid-19/diagnostic-devices-authorized.html
Vitros For updated information on all products listed by the TGA use this link:
Immunodiagnostic https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Products Anti-Sars- devices/covid-19/diagnostic-devices-authorized.html
Cov-2 Total Reagent Ortho-Clinical
Canada
Pack, Vitros Diagnostics Inc.
Immunodiagnostic
Products Anti-Sars-
Cov-2 Total Calibrator
32
For updated information on all products listed by the TGA use this link:
Elecsys Anti-SARS- Roche Diagnostics
CoV-2 Gmbh (Germany)
Qiastat-DX For updated information on all products listed by the TGA use this link:
Qiagen Gmbh
Canada Respiratory SARS- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(Germany)
CoV-2 Panel devices/covid-19/diagnostic-devices-authorized.html
Biofire Respiratory Biofire Diagnostics, LLC.
Panel 2.1 (RP2.1) (United States)
Abbott Laboratories, For updated information on all products listed by the TGA use this link:
Canada SARS-CoV-2 IgG Assay Diagnostics Division https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(United States) devices/covid-19/diagnostic-devices-authorized.html
Liaison SARS-Cov-2
Canada Diasorin Inc. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
S1/S2 IgG
Biofire COVID - 19 For updated information on all products listed by the TGA use this link:
Test & Biofire COVID https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Biofire Defense LLC
Canada - 19 External Control devices/covid-19/diagnostic-devices-authorized.html
(United States)
Test Kit (+)Table 1 -
Footnote 2
Real-time For updated information on all products listed by the TGA use this link:
Fluorescent RT-PCR BGI Americas Corp. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada
Kit For Detecting (China) devices/covid-19/diagnostic-devices-authorized.html
SARS-2019-nCoV
Genefinder CoVid-19 Osang Healthcare Co.,
Plus Realamp Kit Ltd. (South Korea)
BD SARS-CoV-2 For updated information on all products listed by the TGA use this link:
Becton Dickinson and
Canada Reagents For BD Max https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Company (Canada)
System devices/covid-19/diagnostic-devices-authorized.html
Allplex 2019-NCoV For updated information on all products listed by the TGA use this link:
Canada Seegene Inc.
Assay
33
DiaSorin Simplexa For updated information on all products listed by the TGA use this link:
COVID-19 Direct https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada Molecular Assay on DiaSorin Molecular LLC devices/covid-19/diagnostic-devices-authorized.html
the LIAISON MDX
Instrument
PerkinElmer New For updated information on all products listed by the TGA use this link:
PerkinElmer, Inc.
Canada Coronavirus Nucleic https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(United States)
Acid Detection Kit devices/covid-19/diagnostic-devices-authorized.html
DiaPlexQ Novel For updated information on all products listed by the TGA use this link:
Canada Coronavirus (2019- Solgent Co., Ltd. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
nCoV) Detection Kit devices/covid-19/diagnostic-devices-authorized.html
1DROP INC. (imported For updated information on all products listed by the TGA use this link:
1copy COVID-19
Canada by Luminarie Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
QPCR Multi Kit
Inc.) devices/covid-19/diagnostic-devices-authorized.html
NxTAG COV Extended Luminex Molecular
Panel Diagnostics, Inc.
Abbott Realtime
Canada Abbott Molecular Inc. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
SARS-COV-2 Assay
Diagnostic Hybrids, Inc. - For updated information on all products listed by the TGA use this link:
LYRA SARS-COV-2 Also trading as Quidel https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada
ASSAY Corporation (United devices/covid-19/diagnostic-devices-authorized.html
States)
Panther Fusion For updated information on all products listed by the TGA use this link:
Hologic, Inc. (United
Canada System - SARS-CoV-2 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
States)
Assay devices/covid-19/diagnostic-devices-authorized.html
Xpert Xpress SARS-
Canada Cepheid (United States) https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
CoV-2
34
TaqPathTM COVID-19 Thermo Fisher (United
Combo Kit States)
Japan 2019-nCoV For updated information on all products listed by the TGA use this link:
https://www.mhlw.go.jp/stf/newpage_11332.html
Fluorescence
Sysmex Corporation and
Detection Real- https://www.pmda.go.jp/english/about-pmda/0002.html
time RT-PCR Kit
Japan Loopamp Novel For updated information on all products listed by the TGA use this link:
Coronavirus 2019 Eiken Chemical Co.,
and
(SARS-CoV-2) Ltd. https://www.pmda.go.jp/english/about-pmda/0002.html
Detection Kit
Japan For updated information on all products listed by the TGA use this link:
cobas SARS-CoV- Roche Diagnostics https://www.mhlw.go.jp/stf/newpage_11332.html
2 K.K. and
https://www.pmda.go.jp/english/about-pmda/0002.html
Japan TaqPath Real Time For updated information on all products listed by the TGA use this link:
Life Technologies https://www.mhlw.go.jp/stf/newpage_11332.html
PCR Reagent Kit
Japan Ltd. and
for SARS-CoV-2 https://www.pmda.go.jp/english/about-pmda/0002.html
Japan Cepheid Inc., For updated information on all products listed by the TGA use this link:
Xpert® Xpress https://www.mhlw.go.jp/stf/newpage_11332.html
Beckman Coulter,
SARS-CoV-2 and
Inc. https://www.pmda.go.jp/english/about-pmda/0002.html
ESPLINE SARS- https://www.mhlw.go.jp/stf/newpage_11332.html
Fujirebio Inc.
CoV-2 and
Japan MEBRIGHT SARS- MEDICAL＆ For updated information on all products listed by the TGA use this link:
CoV-2 Kit BIOLOGICAL
35
LABORATORIES CO., and

LTD.
Japan FilmArray For updated information on all products listed by the TGA use this link:
bioMérieux Japan https://www.mhlw.go.jp/stf/newpage_11332.html
Respiratory Panel
Ltd. and
2.1 https://www.pmda.go.jp/english/about-pmda/0002.html
Lumipulse G https://www.mhlw.go.jp/stf/newpage_11332.html
Fujirebio Inc.
SARS-CoV-2 Ag and
GENECUBE SARS- https://www.mhlw.go.jp/stf/newpage_11332.html
TOYOBO CO., LTD.
CoV-2 and
TRCReady SARS- TOSOH https://www.mhlw.go.jp/stf/newpage_11332.html
CoV-2 CORPORATION and
QuickNavi- https://www.mhlw.go.jp/stf/newpage_11332.html
Denka Co., Ltd.
COVID19 Ag and
SmartAmp SARS- https://www.mhlw.go.jp/stf/newpage_11332.html
K.K. DNAFORM
CoV-2 and
Aptima SARS-CoV- https://www.mhlw.go.jp/stf/newpage_11332.html
Hologic Japan, Inc.
2 and
Australia Abbott RealTime Abbott Australasia Pty For updated information on all products listed by the TGA use this link:
SARS-CoV-2 Ltd Molecular Division https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
36
Australia Abbott Ireland For updated information on all products listed by the TGA use this link:
SARS-CoV-2 IgG Kit Diagnostic Division https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Ireland)
Australia NOVA Test® COVID- Atlaslink Beijing For updated information on all products listed by the TGA use this link:
19 IgG/IgM Antibody Technology Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Test (Colloidal Gold) (China)
Australia AtomoRapid™ For updated information on all products listed by the TGA use this link:
Atomo Diagnostics
COVID-19 IgM/IgG https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Limited (Australia)
Antibody Test
Australia AusDiagnostics For updated information on all products listed by the TGA use this link:
respiratory virus AusDiagnostics Pty Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
panel (including (Australia)
SARS-CoV-2) test
Australia Beckman Coulter Inc For updated information on all products listed by the TGA use this link:
Access SARS-CoV-2
(United States Of https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgG Antibody Test
America)
Australia BD SARS-CoV-2 Becton Dickinson and For updated information on all products listed by the TGA use this link:
Reagents for BD Company (United States https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
MAX™ System Of America)
Australia Beijing Wantai For updated information on all products listed by the TGA use this link:
Wantai SARS-CoV-2 Biologicalpharmacy https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Ab Rapid Test kit Enterprise Co Ltd
(China)
Australia Real-time fluorescent For updated information on all products listed by the TGA use this link:
BGI Europe A/S
RT-PCR kit for https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Denmark)
detecting SARS-CoV-2
Australia For updated information on all products listed by the TGA use this link:
Platelia SARS-CoV-2
Bio-Rad (France) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Total Ab
Australia Bio-Core 2019-nCoV BioCore Co Ltd (Korea - For updated information on all products listed by the TGA use this link:
Real Time PCR Kit Republic of) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
37
Australia BioFire Respiratory For updated information on all products listed by the TGA use this link:
Panel 2.1 plus BioFire Diagnostics LLC https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(RP2.1plus)
SARS-COV-2 R-GENE® Biomerieux SA (France) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
VIDAS® SARS-COV-2
Biomerieux SA (France) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM
VIDAS® SARS-COV-2
Biomerieux SA (France) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgG
Australia Cellex qSARS-CoV-2 For updated information on all products listed by the TGA use this link:
Cellex Inc (United States
IgG/IgM Cassette https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Of America)
Rapid Test kit
Xpert® Xpress SARS-
Cepheid (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2
Australia VIASURE SARS-CoV-2 For updated information on all products listed by the TGA use this link:
Real Time PCR CerTest Biotec SL (Spain) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Detection Kit
Australia VIASURE SARS-CoV-2 For updated information on all products listed by the TGA use this link:
S gene Real Time PCR CerTest Biotec SL (Spain) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Detection Kit
Australia Logix Smart™ Co-Diagnostics Inc For updated information on all products listed by the TGA use this link:
Coronavirus Disease (United States Of https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
2019 (COVID-19) Kit America)
Aridia COVID-19 Real- CTK Biotech Inc (United https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Time PCR Test States Of America)
38
OnSite COVID-19 https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgG/IgM Rapid Test CTK Biotech Inc (USA)
Australia DiaSorin Molecular LLC For updated information on all products listed by the TGA use this link:
Simplexa™ COVID-19 (United States Of https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Direct America)
LIAISON® SARS-CoV-2 https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM DiaSorin SpA (Italy)
LIAISON® SARS-CoV-2 https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
S1/S2 IgG DiaSorin SpA (Italy)
Australia EUROIMMUN For updated information on all products listed by the TGA use this link:
Medizinische https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Anti-SARS-CoV-2 Labordiagnostika AG
ELISA (IgA) (Germany)
Anti-SARS-CoV-2 Labordiagnostika AG
ELISA (IgG) (Germany)
EURORealTime SARS- Labordiagnostika AG
CoV-2 (Germany)
Anti-SARS-CoV-2 NCP Labordiagnostika AG
ELISA (IgG) (Germany)
Anti-SARS-CoV-2 NCP Labordiagnostika AG
ELISA (IgM) (Germany)
39
GenBody COVID-19 GenBody Inc (Korea - https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG Republic of)
GB SARS-CoV-2 Real General Biologicals Corp https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Time RT-PCR (Taiwan)
EasyScreen™ SARS- Genetic Signatures Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2 Detection Kit (Australia)
Australia SARS-CoV-2 Antibody For updated information on all products listed by the TGA use this link:
Test (Lateral Flow Guangzhou Wondfo https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Method) Biotech Co Ltd (China)
Test (Lateral Flow Guangzhou Wondfo https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Test (Lateral Flow Guanngzhou Wondfo https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
2019-n-CoV IgG/IgM Hangzhou Alltest https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Cassette Biotech Co Ltd (China)
COVID-19 IgG/IgM Hangzhou Biotest https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
COVID-19 IgG/IgM Hangzhou Clongene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Australia Novel Coronavirus For updated information on all products listed by the TGA use this link:
(2019-nCoV) IgM/IgG https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Antibody Combo Test Hangzhou Laihe Biotech
Kit (Colloidal Gold) Co Ltd (China)
40
Australia 2019-nCOV/COVID- For updated information on all products listed by the TGA use this link:
19 IgG/IgM Rapid Hangzhou Realy Tech Co https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Test Device Ltd (China)
Australia Healgen Scientific For updated information on all products listed by the TGA use this link:
Limited Liability https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
COVID-19 IgG/IgM Company (United States
Rapid Test Cassette Of America)
Aptima® SARS-CoV-2 Hologic Inc (United https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Assay States Of America)
Australia Panther Fusion® For updated information on all products listed by the TGA use this link:
SARS-CoV-2 Assay https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Panther Fusion®
System) Hologic Inc (USA)
Australia InnoScreenTM For updated information on all products listed by the TGA use this link:
COVID-19 IgG/IgM Innovation Scientific Pty https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Ltd (Australia)
Australia Innovita (Tangshan) For updated information on all products listed by the TGA use this link:
2019-nCoV Ab Test Biological Technology https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Colloidal Gold) Co Ltd (China)
Australia COVID-19 Jiangsu Bioperfectus For updated information on all products listed by the TGA use this link:
Coronavirus Real Technologies Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Time PCR Kit (China)
Australia PowerChekTM 2019- For updated information on all products listed by the TGA use this link:
nCoV Real-time PCR Kogene Biotech Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Kit (Korea - Republic of)
LabGun™ COVID-19 Labgenomics Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
RT-PCR Kit (Korea - Republic of)
TaqPath COVID-19 Life Technologies https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Combo Kit Corporation (USA)
41
Australia Nantong Egens For updated information on all products listed by the TGA use this link:
COVID-19 IgG/IgM Biotechnology Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Kit (China)
Australia Newscen Coast Bio- For updated information on all products listed by the TGA use this link:
COVID-19 IgG/IgM Pharmaceutical Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Cassette (China)
Australia NTBIO One Step For updated information on all products listed by the TGA use this link:
Rapid Test - COVID- https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
19 IgG/IgM Antibody NTBIO Diagnostics Inc
Test (Canada)
Australia VITROS For updated information on all products listed by the TGA use this link:
Immunodiagnostic Ortho-Clinical https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Products Anti-SARS- Diagnostics (United
CoV-2 Total Kingdom)
GeneFinder™ COVID- OSANG Healthcare Co https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
19 Plus RealAmp Kit Ltd (Korea - Republic of)
PCL COVID19 IgG/IgM PCL Inc (Korea - https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Gold Republic of)
Australia IAstat-Dx® For updated information on all products listed by the TGA use this link:
Respiratory SARS- https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2 Panel Qiagen GmbH
SARS-CoV-2 IgM/IgG Qingdao Hightop https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Antibody Rapid Test Biotech Co Ltd (China)
Elecsys Anti-SARS- Roche Diagnostics https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2 GmbH (Germany)
Roche Molecular https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
cobas® SARS-CoV-2 Systems Inc (USA)
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(2019-nCoV) Nucleic https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Acid Diagnostic Kit
(PCR-Fluorescence Sansure Biotech Inc
Probing) (China)
Allplex™ 2019-nCoV Seegene Inc (Korea - https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Assay Republic of)
Allplex™ SARS-CoV-2 Seegene Inc (Korea - https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Assay Republic of)
Australia Novel Coronavirus Shanghai Fosun Long For updated information on all products listed by the TGA use this link:
(2019-nCoV) RT-PCR March Medical Science https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Detection Kit Co Ltd (China)
(2019-nCoV) Real https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Time Multiplex RT-
PCR Kit (Detection for Shanghai ZJ Bio-Tech Co
3 genes) Ltd (China)
iFlash-SARS-CoV-2 Shenzhen YHLO Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgG Co Ltd (China)
iFlash-SARS-CoV-2 Shenzhen YHLO Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM Co Ltd (China)
Australia Dimension Vista® For updated information on all products listed by the TGA use this link:
SARS-CoV-2 Total Siemens Healthcare https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
antibody assay Diagnostics Inc (United
(COV2T) States Of America)
Australia Atellica® IM SARS- Siemens Healthcare For updated information on all products listed by the TGA use this link:
CoV-2 Total (COV2T) Diagnostics Inc (United https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
assay States Of America)
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Australia ADVIA Centaur® Siemens Healthcare For updated information on all products listed by the TGA use this link:
SARS-CoV-2 Total Diagnostics Inc (United https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(COV2T) assay States Of America)
Australia Dimension EXL SARS- Siemens Healthcare For updated information on all products listed by the TGA use this link:
CoV-2 Total antibody Diagnostics Inc (United https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
assay (CV2T) States Of America)
Australia PerkinElmer® SARS- Suzhou Sym-Bio For updated information on all products listed by the TGA use this link:
CoV-2 Real-time RT- Lifescience Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
PCR Assay (China)
Australia EasyNat Diagnostic For updated information on all products listed by the TGA use this link:
Kit for Novel- https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Coronavirus (2019-
nCoV) RNA
(Isothermal
Amplification-Real Ustar Biotechnologies
Time Fluorescence (Hangzhou) Co Ltd
Assay) (China)
Australia VivaCheck Biotech For updated information on all products listed by the TGA use this link:
VivaDiag™ COVID-19 (Hangzhou) Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG Rapid Test (China)
Australia VivaChek Biotech For updated information on all products listed by the TGA use this link:
Australia VivaChek Biotech For updated information on all products listed by the TGA use this link:
Australia COVID-19 (SARS-CoV- Wuhan EasyDiagnosis For updated information on all products listed by the TGA use this link:
2) Nucleic Acid Test Biomedicine Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
kit (China)
Australia Wuhan EasyDiagnosis For updated information on all products listed by the TGA use this link:
SARS-CoV-2 IgM/IgG Biomedicine Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Antibody Test Kit (China)
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COVID-19 IgG/IgM Zhejiang Orient Gene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
COVID-19 IgG/IgM Zhejiang Orient Gene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
COVID 19 IgG/IgM Zhejiang Orient Gene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Australia Diagnostic Kit for For updated information on all products listed by the TGA use this link:
IgM/IgG Antibody to https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Coronavirus (SARS- Zhuhai Livzon
CoV-2) (Lateral Flow) Diagnostics Inc (China)
Australia Diagnostic Kit for For updated information on all products listed by the TGA use this link:
IgM/IgG Antibody to https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Coronavirus (SARS- Zhuhai Livzon
CoV-2) (Lateral Flow) Diagnostics Inc (China)
SARS-CoV-2 RT-qPCR https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Reagent Kit Wallac Oy (Finland)
Australia Veri-Q PCR 316 For updated information on all products listed by the TGA use this link:
COVID-19 Detection MiCoBioMed Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Kit (Korea - Republic of)
Australia Abbott Molecular Inc For updated information on all products listed by the TGA use this link:
Alinity m SARS-CoV-2 (United States Of https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
AMP Kit America)
CareStart™ COVID-19 Access Bio Inc (United https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
MDx RT-PCR States Of America)
Australia Quidel Corporation For updated information on all products listed by the TGA use this link:
Sofia® SARS Antigen (United States Of https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
FIA America)
45
Australia Vela Operations For updated information on all products listed by the TGA use this link:
ViroKey™ SARS-CoV-2 Singapore Pte Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
RT-PCR Test v2.0 (Singapore)
Singapore For updated information on all products listed by the HSA use this link:
Diagnostics https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
FORTITUDE KIT 2.0E 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Development Hub (DxD)
VereCoV™ Detection Veredus Laboratories
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Kit Pte Ltd
19-diagnostic-tests-in-singapore-via-provisional-authorisation
abTES™ COVID-19
AITbiotech Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
qPCR I Kit
Singapore Real-Time PCR Assay For updated information on all products listed by the HSA use this link:
DSO National
for the Detection of https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Laboratories
SARS-CoV-2 Virus 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Roche Diagnostics Asia
Cobas® SARS-CoV-2 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pacific Pte Ltd
ProTect™ COVID-19
JN Medsys Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
RT-qPCR Kit
TaqPath™ COVID-19 Life Technologies
Combo Kit Holdings Pte Ltd
VivaDiag™ COVID-19
Everest Links Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
IgM/IgG Rapid Test
Singapore Nanjing Vazyme For updated information on all products listed by the HSA use this link:
2019-nCoV IgG/IgM Biolidics Limited https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Detection Kit 19-diagnostic-tests-in-singapore-via-provisional-authorisation
46
Singapore Kit for Novel- For updated information on all products listed by the HSA use this link:
Coronavirus (2019- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) RNA 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(Isothermal Biowalker Pte Ltd
Amplification-Real
Time Fluorescence
Assay)
Cepheid® Xpert®
SPD Scientific Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Xpress SARS-CoV-2
MiRXES FORTITUDE
MiRXES Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
KIT 2.0
Acumen Research
Acu-Corona™ 2.0 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Laboratories
VitaPCR™ SARS-CoV- Credo Diagnostics
2 Assay Biomedical Pte Ltd
Abbott RealTime Abbott Laboratories
SARS-CoV-2 assay (Singapore) Pte Ltd
Singapore Seegene For updated information on all products listed by the HSA use this link:
All Eights (Singapore)
AllplexTM 2019-nCoV https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
Assay 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Wondfo SARS-CoV-2
SkyQuest Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Antibody Test
Camtech COVID-19 Camtech Diagnostics Pte
IgM/IgG Ltd
47
Acumen Research
Acu-Corona 3.0 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Laboratories Pte Ltd
ViroKey SARS-CoV-2 Vela Operations
RT-PCR Test Singapore Pte Ltd
Singapore PerkinElmer® SARS- For updated information on all products listed by the HSA use this link:
PerkinElmer Singapore
CoV-2 Real-time RT- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
PCR Assay 19-diagnostic-tests-in-singapore-via-provisional-authorisation
BioWalker SARS-CoV-
BioWalker Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2 Assay
Singapore Sansure Biotech For updated information on all products listed by the HSA use this link:
Novel https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Medicell Pharmaceutical
Coronavirus(2019- 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(S) Pte Ltd
nCoV) Nucleic Acid
Diagnostic Kit
Singapore DiagnoSure COVID-19 For updated information on all products listed by the HSA use this link:
IgG/ IgM Rapid Test Grit Overseas Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Cassette 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Real-time fluorescent For updated information on all products listed by the HSA use this link:
BGI Health (SG)
RT-PCR kit for https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Company Pte Ltd
detecting 2019-nCoV 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Shanghai LiangRun For updated information on all products listed by the HSA use this link:
LionRun Diagnostic https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Kit for Antibody IgM- Veredus Laboratories 19-diagnostic-tests-in-singapore-via-provisional-authorisation
IgG of Novel Pte Ltd
Coronavirus COVID-
19
Singapore INNOVITA 2019-nCoV For updated information on all products listed by the HSA use this link:
Bioforge Solutions Pte
Ab Test (Colloidal https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
Gold) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
48
Singapore Wondfo SARS-CoV-2 For updated information on all products listed by the HSA use this link:
Antibody Test Bioforge Solutions Pte https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
(Lateral Flow Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Method)
Diagnostics
Fortitude™ Kit 2.1 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Development Hub (DxD)
Singapore Abbott SARS-CoV-2 For updated information on all products listed by the HSA use this link:
Abbott Laboratories (S)
IgG – ARCHITECT https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
assay 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Allplex 2019-nCoV Genomax Technologies
Assay Pte Ltd
BioWalker SARS-CoV-
BioWalker Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2 Assay 2.0
Singapore Liferiver Novel For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Tanglin Cardiology Pte https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) Real Time Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Multiplex RT-PCR Kit
Roche Elecsys Anti- Roche Diagnostics Asia
SARS-CoV-2 Pacific Pte Ltd
Singapore BD SARS-CoV-2 For updated information on all products listed by the HSA use this link:
Becton Dickinson
Reagents for BD https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Holding Ptd Ltd
MAX™ System 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Liferiver Novel For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Biomed Diagnostics Pte https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) Real Time Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Multiplex RT-PCR Kit
Singapore VITROS Ortho Clinical For updated information on all products listed by the HSA use this link:
Immunodiagnostic Diagnostics
49
Products Anti-SARS- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-

CoV-2 Total Reagent 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Pack
Singapore MP Diagnostics For updated information on all products listed by the HSA use this link:
MP Biomedicals Asia
ASSURE® SARS-CoV-2 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pacific Pte Ltd
IgG/IgM Rapid Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Biomed Diagnostics Pte
Ltd
Luminex NxTAG® CoV Biomed Diagnostics Pte
Extended Panel Assay Ltd
Singapore SARS-CoV-2 For updated information on all products listed by the HSA use this link:
Neutralization Genscript Biotech https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Antibody Detection (Singapore) Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Kit
MiRXES Fortitude Kit
MiRXES Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2.1
Singapore Xiamen Boson Rapid For updated information on all products listed by the HSA use this link:
Trans Sahara
2019-nCOV IgG/IgM https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Corporation Pte Ltd
Combo Test Card 19-diagnostic-tests-in-singapore-via-provisional-authorisation
BioFire® Respiratory BioMérieux Singapore
Panel 2.1 (RP2.1) Pte Ltd
GeneFinder™ COVID-
19 Plus RealAmp Kit
Singapore EDI™ Novel For updated information on all products listed by the HSA use this link:
Coronavirus COVID- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
19 IgG ELISA Kit 19-diagnostic-tests-in-singapore-via-provisional-authorisation
50
Singapore EDI™ Novel For updated information on all products listed by the HSA use this link:
Coronavirus COVID- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
19 IgM ELISA Kit 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore altona Diagnostics For updated information on all products listed by the HSA use this link:
RealStar™ SARS-CoV- SDT Molecular Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2 RT-PCR Kit 1.0 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore HealthGroup Medical For updated information on all products listed by the HSA use this link:
V-CODE Sars-CoV-2 Healthgroup Medical https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
(COVID-19) IgG/IgM Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Rapid Test
AMT RESOLUTE 1.0 AMT Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Singapore i-Test COVID -19 For updated information on all products listed by the HSA use this link:
IgM/IgG Antibody https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
I-Test Pte Ltd
Rapid Test (Colloidal 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Gold)
Ying Assets
Management Pte Ltd
ABBOTT Alinity i Abbott Laboratories (S)
SARS-CoV-2 IgG Pte Ltd
Singapore Fosun Novel For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Novena Global https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) RT-PCR Healthcare Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Detection Kit
BIOSYNEX COVID-19
COBS Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
BSS
Singapore Siemens Healthcare Pte For updated information on all products listed by the HSA use this link:
FTD™ SARS-CoV-2
Ltd
51
Singapore QIAstat-Dx® For updated information on all products listed by the HSA use this link:
Qiagen Singapore Pte.
Respiratory SARS- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
CoV-2 Panel 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore EUROIMMUN Anti- For updated information on all products listed by the HSA use this link:
Euroimmun (South East
SARS-CoV-2 ELISA https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Asia) Pte. Ltd.
(IgG) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
2019-nCoV IgG/IgM
Rapid Test
SARS-CoV-2 Antibody
Trident Pharm Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test Strip
Singapore 2019-nCOV/COVID- For updated information on all products listed by the HSA use this link:
19 IgG/IgM Rapid Sinch Medical Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test Device 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore EUROIMMUN Anti- For updated information on all products listed by the HSA use this link:
Euroimmun (South East
SARS-CoV-2 ELISA https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Asia) Pte. Ltd.
(IgA) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Genrui Novel For updated information on all products listed by the HSA use this link:
Transmedic Pte Ltd
nCoV) IgG/IgM Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Kit (Colloidal Gold)
Singapore Siemens Atellica® IM For updated information on all products listed by the HSA use this link:
Siemens Healthcare Pte
SARS-CoV-2 Total https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
(COV2T) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Siemens ADVIA For updated information on all products listed by the HSA use this link:
Centaur® SARS-CoV-2 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
Total (COV2T) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Standard Q COVID-19 For updated information on all products listed by the HSA use this link:
Xentific Labs Pte Ltd
Ag Test
52
Singapore VereRTCoV™ SARS- For updated information on all products listed by the HSA use this link:
Veredus Laboratories
CoV-2 Real-Time RT- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
PCR 2.0 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore VITROS For updated information on all products listed by the HSA use this link:
Immunodiagnostic https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ortho Clinical
Products Anti-SARS- 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Diagnostics
CoV-2 IgG Reagent
Pack
2019-nCoV IgG/IgM
Alcotech Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Rapid Test Cassette
Singapore RightSign COVID-19 For updated information on all products listed by the HSA use this link:
Unison Collaborative Pte
IgG/IgM Rapid Test https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
Cassette 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Fosun Novel For updated information on all products listed by the HSA use this link:
XIN Pte Ltd
nCoV) RT-PCR 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Detection Kit
VitaPCR™ SARS-CoV- Credo Diagnostics
2 Gen 2 Assay Biomedical Pte Ltd
Luminex ARIES® Biomed Diagnostics Pte
SARS-CoV-2 Assay Ltd
Kaira 2019-nCoV TODOS MEDICAL
Detection Kit SINGAPORE Pte Ltd
Biorad Platelia SARS- Bio-Rad Laboratories
CoV-2 Total Ab (Singapore) Pte Ltd
53
Hologic Aptima® All Eights (Singapore)
SARS-CoV-2 assay Pte Ltd
ACCESS SARS-CoV-2 Beckman Coulter
IgG Singapore Pte Ltd
Singapore Accelerate For updated information on all products listed by the HSA use this link:
Accelerate Technologies
Technologies https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd (DxD Hub)
Resolute 2.0 assay 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Novel Coronavirus For updated information on all products listed by the HSA use this link:
(2019-nCoV) IgM/IgG ZMC Technologies https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Antibody Test Kit (Singapore) Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(Colloidal Gold)
Singapore Panbio™ COVID-19 For updated information on all products listed by the HSA use this link:
Unison Collaborative Pte
Ltd
Device 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore genesig® Real-Time For updated information on all products listed by the HSA use this link:
PCR Coronavirus https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
COVID-19 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Seegene Allplex™ Andaman Medical Pte
SARS-CoV-2 Assay Ltd
Singapore RAS Rapid Test - For updated information on all products listed by the HSA use this link:
RAS Pharma and
2019-nCov IgG/IgM https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Biochem Pte Ltd
Rapid Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Smart COVID-19 IgM- For updated information on all products listed by the HSA use this link:
IgG Rapid Diagnostic Cell ID Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
DSO National
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Laboratories
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Restalyst Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
IgM/IgG Test Kit
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CoV-2 RT-qPCR Kit
ViroKey™ SARS-CoV-2 Vela Operations
RT-PCR Test v2.0 Singapore Pte Ltd
Singapore Novel Coronavirus For updated information on all products listed by the HSA use this link:
(2019-nCoV) Nucleic https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Acid Detection Kit Biotrilance Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(PCR-Fluorescence
Probing)
Singapore Hangzhou Lysun For updated information on all products listed by the HSA use this link:
Genomax Technologies
2019-nCoV IgG/IgM https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
Rapid Test Device 19-diagnostic-tests-in-singapore-via-provisional-authorisation
ProTect COVID-19 RT-
JN Medsys Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
qPCR Kit 2.0
AMT Resolute 2.0
AMT Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
assay
Singapore FaStep COVID-19 For updated information on all products listed by the HSA use this link:
Antigen Rapid Test https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Device Alcotech Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(Nasopharyngeal/
Oropharyngeal Swab)
Singapore Siemens Atellica® IM For updated information on all products listed by the HSA use this link:
SARS-CoV-2 IgG https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
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Singapore Siemens ADVIA For updated information on all products listed by the HSA use this link:
Centaur® SARS-CoV-2 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
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IgG (COV2G) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore SAVANT™ New For updated information on all products listed by the HSA use this link:
Coronavirus (SARS- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
CoV-2) N Protein 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Detection Kit Hi-Beau Group
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Immunochromatogra
phy)
Singapore BD Veritor™ System For updated information on all products listed by the HSA use this link:
Becton Dickinson
for Rapid Detection https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Holding Ptd.Ltd
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Standard Q COVID-19
Ag Test
Singapore genesig® Real-Time For updated information on all products listed by the HSA use this link:
PCR Coronavirus An Xin Home Care https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
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TaqPath™ COVID 19 Life Technologies
CE IVD RT PCR Kit Holdings Pte Ltd
Singapore BioFire® Respiratory For updated information on all products listed by the HSA use this link:
BioMérieux Singapore
Panel 2.1 plus https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
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(RP2.1plus) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore StrongStep® Novel For updated information on all products listed by the HSA use this link:
Coronavirus (SARS- All Eights (Singapore) https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
CoV-2) Multiplex Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Real-Time PCR Kit
Singapore Thermo For updated information on all products listed by the HSA use this link:
Standard Q COVID-19
Scientific_Standard https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ag Test
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Singapore EUROIMMUN EUROIMMUN Anti- For updated information on all products listed by the HSA use this link:
(SOUTH EAST ASIA) SARS-CoV-2 NCP ELISA https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
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Singapore Quantum For updated information on all products listed by the HSA use this link:
Technologies Global Sofia SARS Antigen FIA https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
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i-DNA Biotechnology Maccura SARS-CoV-2
Pte Ltd Fluorescent PCR
Singapore Cheung Yong Sam For updated information on all products listed by the HSA use this link:
COVID-19 (SARS-CoV-2)
Investment Private https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Nucleic Acid Test Kit
Limited 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Restalyst COVID19N- For updated information on all products listed by the HSA use this link:
REAAD™ Anti-SARS-CoV- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Restalyst Pte Ltd
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IgG ELISA
genesig® Real-Time PCR
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COVID-19 (Swab Use)
genesig® Real-Time PCR
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COVID-19 (Swab Use)
Singapore VereRTCoV™ 3.0 For updated information on all products listed by the HSA use this link:
Veredus Laboratories
ZeroStep Real-Time RT- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
PCR 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore DiaPlexQ™ Novel For updated information on all products listed by the HSA use this link:
Link Trust
Laboratories Pte Ltd
nCoV) Detection kit 19-diagnostic-tests-in-singapore-via-provisional-authorisation
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Nova Diagnostics Pte MAGLUMI 2019-nCoV
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Nova Diagnostics Pte MAGLUMI 2019-nCoV
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Singapore FaStep COVID-19 Alcotech Pte Ltd For updated information on all products listed by the HSA use this link:
Device 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore COVID-19 Antigen Jian Yuan Holdings Pte For updated information on all products listed by the HSA use this link:
Rapid Test Kit Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Singapore Camtech COVID-19 Camtech Diagnostics Pte For updated information on all products listed by the HSA use this link:
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Brazil Novo kit de teste de 1000MEDIC For updated information on all products listed by ANVISA use this link:
anticorpos IgM /IgG DISTRIBUIDORA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
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Reagents for BD MAX INDÚSTRIAS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
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Brazil Teste Rápido For updated information on all products listed by ANVISA use this link:
OnSite™ COVID-19 BIO ADVANCE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
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PCR Kit me
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77
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Detection Kit hospitalares ltda epp https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
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phy)
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Brazil SARS-CoV-2 Antibody SETTY ASSESSORIA E For updated information on all products listed by ANVISA use this link:
Test (colloidal gold CONSULTORIA EM https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
immunochromatogra ASSUNTOS
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PROD MEDICO
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phy)
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GenePro SARS-CoV-2 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Test Gencurix Inc.
STANDARD™F COVID- https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
19 IgM/IgG Combo &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Test SD Biosensor Inc
U-TOP COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit SeaSun Biomaterials
Gmate® COVID-19 Philosys Co.,Ltd. &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
101
Asan Easy Test Asan pharmaceutical &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID-19 IgG/IgM Co., LTD.
Veri-Q, nCoV-OM MiCoBioMed, Co., Ltd
EU™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit Eudipia
LabGun™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
RT-PCR Kit LabGenomics, Co., Ltd
DLP™Q COVID 19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Real Detection Kit DIOGENE Co., Ltd
careUS™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG WELLS BIO, INC.
P4DETECT COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG PRIME4DIA Co.,
Dr. PCR 20K COVID- OPTOLANE Technologies https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
19 Detection Kit Inc. &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
102
Axen™COVID-19 RT Macrogen, Inc.
Accurate Rapid https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Combo Test HUMEDIX Co,. Ltd
Biometrix Technology, &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID19+9G test™ Inc.
ChekR™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Rapid test B-bio, Co., Ltd
DIAKEY COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Rapid Test ShinJin Medics Inc.
ADTech COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG ADTceh Co., LTD
CTC™Q COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Combo Test CTCBIO INC.
SsmarTest COVID-19 https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
IgM/IgG Detection Kit SLSBio Co., Ltd &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
103
AllCheck COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgG/IgM CALTH Inc.
NowCheck COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Test BIONOTE, INC.
NowCheck COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Ag Test BIONOTE, INC.
S Korea GG COVID-19 For updated information on all products listed by the MFDS use this link:
Quadplex Reverse https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Transcription Real &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Time Polymerase
Chain Reaction Kit GOODGENE Inc.
DIAKEY REALcheck https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
COVID-19(nCOV) &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection kit ShinJin Medics Inc.
GENEDIA W COVID- GREENCROSS MEDICAL &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
19 IgM/IgG SCIENCE
GENEDIA W ONE GREENCROSS MEDICAL &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID-19 IgM/IgG SCIENCE
China Antibody test kit for Xiamen Innodx Biotech For updated information on all products listed by the NMPA use this link:
novel coronavirus Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
104
2019-nCoV
(chemiluminescence
microparticle
immunoassay)
China Antibody test kit for Guangzhou Wondfo For updated information on all products listed by the NMPA use this link:
novel coronavirus Biotech Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV (colloidal
gold method)
China Antibody test kit for INNOVITA(Tangshan) For updated information on all products listed by the NMPA use this link:
novel coronavirus Biological Technology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV (colloidal Co., Ltd.
gold method)
China IgG Antibody test kit Bioscience (Chongqing) For updated information on all products listed by the NMPA use this link:
for novel coronavirus Diagnostic Technology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV (magnetic Co., Ltd.
particle-based
chemiluminescence
immunoassay)
China IgM antibody test kit Hecin Scientific, Inc. For updated information on all products listed by the NMPA use this link:
for novel coronavirus https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV (colloidal
gold method)
China IgM Antibody test kit Bioscience (Chongqing) For updated information on all products listed by the NMPA use this link:
for novel coronavirus Diagnostic Technology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV (magnetic Co., Ltd.
particle-based
chemiluminescence
immunoassay)
China IgM/IgG antibody test Nanjing Vazyme Medical For updated information on all products listed by the NMPA use this link:
kit for novel Technology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
105
nCoV (colloidal gold

method)
China IgM/IgG antibody test Zhuhai Livzon For updated information on all products listed by the NMPA use this link:
kit for novel Diagnostics Inc. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (colloidal gold
method)
China Nucleic Acid reagent BGI For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnology(Wuhan) https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd.
nCoV (combinatorial
probe-anchor
synthesis sequencing)
China Nucleic Acid reagent Wuhan Zhongzhi For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnologies INC. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (Dual
amplification)
China Nucleic Acid reagent Beijing Applied For updated information on all products listed by the NMPA use this link:
test kit for novel Biological Technologies https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd
nCoV (fluorometric
PCR)
China Nucleic Acid reagent BGI Biotechnology For updated information on all products listed by the NMPA use this link:
test kit for novel (Wuhan) Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Da An Gene Co., Ltd. For updated information on all products listed by the NMPA use this link
test kit for novel https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
106
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Maccura Biotechnology For updated information on all products listed by the NMPA use this link:
test kit for novel Co., Ltd.
coronavirus 2019- https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Sansure Biotech Inc. For updated information on all products listed by the NMPA use this link:
test kit for novel https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai BioGerm For updated information on all products listed by the NMPA use this link:
test kit for novel Medical Biotechnology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai Fosun Long For updated information on all products listed by the NMPA use this link:
test kit for novel March Medical Science https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd.
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai GeneoDx For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai ZJ Bio-Tech For updated information on all products listed by the NMPA use this link:
test kit for novel Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
107
China Nucleic Acid reagent Wuhan Easy Diagnosis For updated information on all products listed by the NMPA use this link:
test kit for novel Biomedicine Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Anbio (Xiamen) For updated information on all products listed by the NMPA use this link:
coronavirus 2019-
nCoV (hybridization
capture
immunofluorescence)
China Nucleic Acid reagent Ustar Biotechnologies For updated information on all products listed by the NMPA use this link:
test kit for novel (Hangzhou) Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (Isothermal
amplification-real
time fluorometric
PCR)
China Nucleic Acid reagent Shanghai Rendu For updated information on all products listed by the NMPA use this link:
coronavirus 2019-
nCoV (RNA capture
probe method)
China Nucleic Acid reagent Wuhan Zhongzhi For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnologies INC. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (RNA isothermal
amplification lateral
flow assay)
China Nucleic Acid reagent Chengdu CapitalBio For updated information on all products listed by the NMPA use this link:
test kit for six Biotechnology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
respiratory viruses
(constant
108
temperature
amplification chip)
For updated information on all products listed by Roszdravnadzor use this link:
Russia Refer to link Refer to link https://www.roszdravnadzor.ru/services/misearch
or
https://medvestnik.ru/chronicles/Odobrennye-testy-COVID.html
For updated information on all products listed by the EU use this link:
EU Refer to link Refer to link https://covid-19-diagnostics.jrc.ec.europa.eu/devices#form_content
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