RT PCR Tests Kits Evaluation Summ 17022022

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भारतीय आयुर्विज्ञान अनुसध

ं ान पररषद
स्वास््य अनुसंधान ववभाग, स्वास््य और पररवार
कल्याण मंत्रालय, भारत सरकार
Indian Council of Medical Research
Department of Health Research, Ministry of Health
and Family Welfare, Government of India

Date: 17/02/2022

PERFORMANCE EVALUATION OF COMMERCIAL KITS FOR REAL TIME PCR FOR COVID BY
ICMR IDENTIFIED VALIDATION CENTRES
Till date, 523 RT-PCR kits have been evaluated by ICMR validation centres, and the following
were found to be satisfactory.
Sl. Name of Company Name of the Kit *Batch Number Origin
No
1 1Drop Inc, Korea (Nandan Exports & 1copy COVID-19 qPCR Triplex Kit M230H1900 Imported
Imports Private Limited)
2 3B Black Bio Biotech India Ltd., TRUPCR SARS-CoV-2 RT-qPCR Kit CoV- Domestic
Bhopal, India (V-3.2) (Single Tube Multiplex 19/V3.2/2020/02
format)
3 AB Diagnopath Manufacturing Pvt. Ltd. InnoDetectTM CL COVID-19 Iso- ABDM/R&D01/C Domestic
PCR kit OV/ISOPCR
4 AB Diagnopath Mfg. Pvt. Ltd, Delhi, InnoDetect Covid-19 RT-PCR Kit ABDM/R&D01/C Domestic
India OVRTPCR
5 ABI (Applied bio-systems), USA TaqMan 2019-nCoV Control Kit v1 47532-020720 Imported
6 Accelerate Technologies Pte.ltd (DxD A*STAR FORTITUDE KIT 2.0 200304 Imported
Hub), Singapore 200402
7 Accurex Biomedical Pvt Ltd, Palghar, Accurex SARS COVID-19 RT-PCR CRV1D001 Domestic
Maharashtra Assay
8 Accurex Biomedical Pvt Ltd, Palghar, Novel Coronavirus (2019-nCoV) DCRPT001 Domestic
Maharashtra Nucleic Acid Detection Kit
(Fluorescence PCR Method)
9 Achira labs Pvt Ltd GenePath Dx CoviSpeedy ACH/CVS/19102 Domestic
021/001
10 ACHIRA LABS PVT. LTD GENEPATH DX CoviQuick v2.0 ACH/CQK/10062 Domestic
1/004
11 Achira Labs Pvt. Ltd., Bengaluru, Gene path Dx CoVi Delta RT-qPCR 20210809A Domestic
Karnataka Kit v ME-2
12 Acrannolife Genomics Pvt. Ltd., COVIQWIK SARS-CoV-2 RT-LAMP A100232 Domestic
Kit
13 ADALTIS S.r.l, Italy (PUG Capital MOLgen SARS CoV-2 Realtime RT- 20167 Imported
Private Limited) PCR kit
14 ADT Biotech Sdn. Bhd. (ADT India LyteStar 2019-nCoV RT-PCR Kit 2.0 nCoV-2008-01ST Domestic
Private Limited)
15 ADT India Ltd, New Delhi, India LyteStar 2019-nCoV RT PCR Kit 1.0 nCOV-2003-06 Domestic
nCOV-2004-02
nCOV-2004-03
SARS-2004-01
SARS-2004-02
SARS-2004-03
16 Advanced Molecular Diagnostics Zena Max SARS-CoV-2 Direct qPCR 11382 Imported
(AMD), UK (Diagnostic Biosystems) Detection Kit
17 Affigenix Biosolutions Pvt. Ltd Holborn Wells Detect SARS-CoV-2 HBI001A Domestic
Multiplex IVD RT-QPCR TEST Kit
18 Affigenix Biosolutions Pvt. Ltd RT-QPCR TEST Kit HDI0001A Domestic
19 AffigenixBiosolutions Pvt Ltd, AFFIGENIX COVID 19 TEST (ACT- MX07/3G/08_MF Domestic
Bangalore, India 1) (3 Genes MULTIPLEX KIT) G
20 AffigenixBiosolutionsPvt. Ltd, AffigenixCovid 19 test (ACT) kit AFDX1000602 Domestic
Bangalore
21 Agappe Diagnostics Ltd, Kerala Direct Covid 19 LAMP Test Kit R007101 Domestic
22 Agappe Diagnostics Ltd, Kerala, India Agappe Real Time RT – LAMP R008003 Domestic
COVID 19 Testing Kit
23 AITbiotech Pte Ltd, Singapore abTES COVID-19 qPCR I Kit (v1.1) L141-173 Imported
(Hiddenite Beverages Private Limited)
24 AITbiotech Pte Ltd, Singapore abTESTM COVID-19 qPCR I Kit L141-57 Imported
(Hiddenite Beverages Private Limited)
25 Ajay Bio-Tech (India) Ltd. PATHOFIND COVID-19 Realtime 20200601 Domestic
RT-PCR Kit
26 Alchem Diagnostics, Coimbatore COVID-19, ONE STEP MULTIPLEX BPORT210805 Domestic
RT PCR KIT
27 Altona Diagnostics, Germany RealStar SARS-CoV-2 RT-PCR kit 23005 Imported
1.0 24628
28 Ammagen, Tamil Nadu Ammagen RT-PCR Kit AGBRTP210103 Domestic
29 Angstrom Biotech Pvt. Ltd, Rajasthan ANGPCR 2019-nCoV COVP02 Domestic
30 Aspen Laboratories Pvt. Ltd, New Delhi Aspen SARS-CoV-2 Nucelic acid 7020 Domestic
(Deep Meditech Pvt Ltd) detection kit (PCR- Fluorescent probe
method)
31 Athenese-Dx Private Limited, Tamil Aridia CoVid-19 Real Time PCR AP1708201 Domestic
Nadu Detection Kit
32 Aura Biotechnologies Private Limited, Aura’s CORONAVIRUS (COVID-19) LD12020005 Domestic
Chennai Real Time PCR DETECTION KIT
33 AvienceBiomedicals Pvt Ltd, Delhi Avien Covi Quick Covid-19 Hid AVVI-0001 Domestic
RTqPCR Assay
34 AvienceBiomedicals Pvt Ltd, Delhi AvienBio COVID-19 RT PCR Assay AV-000001 Domestic
35 Axiva Sichem Biotech, Sonipat One-Step RT-PCR Test for Covid-19 RPC/010921/D/0 Domestic
1
36 BAG Diagnostics, Germany (Shiva ViroQ SARS-CoV-2 (E gene + RdRp) 002VM1 Domestic
Scientific Company, New Delhi)
37 BGI Genomics, China Real Time Fluorescent RT-PCR Kit 6020200107 Imported
for detecting 2019-nCoV
38 Bhat Biotech India Pvt Ltd GENEASY COVID-19 RT-PCR Kit COVID20200601 Domestic
39 BioGenex Hyderabad COVID-19 TRIPLEX RT-PCR TRI010- Domestic
DIRECT, SARS-CoV-2 DETECTION 26JULY21
KIT
40 Biogenix INC Pvt Ltd, Lucknow Biogenix Covid-19 one step RT PCR 20200412 Domestic
41 BioGenomics Limited, Thane, India BIO COVID ID/COVID-19 qualitative BGL/IVD/COV/0 Domestic
PCR detection kit version 2 420/004
42 BioGenomics Limited, Thane, India BioCov-iD ERN Corona Virus Single BGL/IVDM/COV Domestic
Tube Multiplex RT-PCR Detection Kit /ERN/1020/009
43 Bioneer Corporation, South Korea AccuPower SARS-CoV-2 Real Time 200231E Imported
(Effibar India Private Limited) RT-PCR Kit
44 Bioneer Corporation, South Korea AccuPower SARS-CoV-2 Multiplex 200231G Imported
(Wevio Global Private Limited) Real Time RT-PCR Kit
45 Bioneer Corporation, South Korea AccuPower SARS-CoV-2 Real Time 200331E Imported
(Wevio Global Private Limited) RT-PCR Kit
46 Biosci Healthcare, Madhya Pradesh BioSci True Detect COVID-19 Real C19PCR003 Domestic
Time PCR Kit
47 BioSewoom, South Korea Real-Q 2019-nCoV Detection Kit 580L-008 Imported
48 BioSystems Diagnostics Private Limited Concepta CoViDx RT-qPCR Kit T001 Domestic
49 BioSystems Diagnostics Private Limited CoviPlus RT-qPCR Kit T-02 Domestic
50 BioSystems Diagnostics Pvt. Ltd Concepta COVID-19 Multiplex RT P-T 01 Domestic
PCR Kit
51 Bogar Bio Bee Stores Pvt Ltd., Bio Bee COVID19 Detection Kit BBSRTPCR21- Domestic
002
52 Cancer Rop Co. Ltd (Anjanajyoti Q Sens 2019-nCoV Detection Kit Q-12C Domestic
Systems Private Limited)
53 Cepheid, United States Xpert Xpress SARS-CoV-2 1000191996 Imported
1000191998
1000191999
54 Cepheid, United States (Cepheid India Xpert Xpress SARS-CoV-2 1000206864 Imported
Private Limited)
55 ChemGenes Corporation, USA ChemGenes IQ-4 SARS CoV-2 IQ4- Imported
(ChemGenes India Pvt. Ltd) Multiplex Kit CVD_MPDB-
1020 [IQ4-xxx-
L10320]
56 CoSara DiagnosticsPvt. Limited, SARAGENE COVID-19 V.2 Real 20K12PE-01 Domestic
Ahmedabad, India Time PCR Test Kit
57 CoSara DiagnosticsPvt. Limited, SARAGENETM Corona Virus (2019 20C11PE-01 Domestic
Ahmedabad, India NCV) Test Kit
58 Daan Gene Co. Ltd., China Daan Gene Co. Ltd 2020007 Imported
59 Diasolex Solutions LLP, Karnataka, DX-CoV-2 RT-PCR kit DX0001 Domestic
India
60 DNA technology Research & SARS-CoV-2/SARS-CoV Multiplex F2005S-2M Imported
Production, LLC, Russia (365 Medical Rteal-Time PCR detection kit
India)
61 DNA XpertPvt. Ltd, Noida, India XpertCovido 19-Fast RT-PCR kit XC19-01 Domestic
62 DNA XpertPvt. Ltd, Noida, India Xperts Covido19 Multiplex RT-PCR MP-20-01 Domestic
kit
63 Equine Biotech, Karnataka (EBT PVT Global COVID 19 Kit EBT002 Domestic
LTD)
64 EUROIMMUN, UK (CPC Diagnostics EURO Real Time SARS CoV-2 I200428CF Imported
Pvt Ltd)
65 GCC Biotech India Private Limited DiagSure nCOV-19 Detection assay 20115K1278 Domestic
(Taqman based) 20115k1251
66 GCC Biotech India Private Limited DiagSurenCOV 19 Detection assay 20115K1310 Domestic
(Multiplex Taqman)
67 Gene Path Diagnostics, Pune, India GenePathCoViDx One RT-qPCR 20200504A Domestic
v2.1.1
68 Gene Proof, Czech Republic Gene Proof SARS-CoV-2 PCR kit 2025500 Imported
69 Gene Proof, Czech Republic Gene Proof SARS-CoV-2 Screening 2025671 Imported
PCR kit 2025455
70 Genedrive Diagnostics Limited, UK 96 SARS-CoV-2 Kit 210803 Imported
(Pinktech Design Private Limited,
Delhi)
71 GeneMatrix, South Korea NeoPlex COVID-19 detection kit NR05A Imported
72 General Biologicals Corporation, GB SARS-CoV-2 Real Time PCR (E PVT6068 Imported
Taiwan (Innvolution Limited, New + ORF1ab gene + IC)
Delhi)
73 GeneReach Biotechnology Corporation, IQ Real SARS-CoV-2 Qualitative 31320 Imported
Taiwan (Padmanabha Labs Pvt. Ltd.) System
74 Genes 2 Me Private Limited Genes2me CoV Flu one step RT PCR G2M270001 Domestic
Kit
75 Genes 2 Me Private Limited Genes2Me RT-DIRECT Multiplex G2M20001 Domestic
Real Time PCR Kit for COVID-19
76 Genes 2 Me Private Limited COVIDtect Multiplex RT-PCR Kit for G2M300001 Domestic
SARS-CoV-2
77 Genes 2 Me Private Limited VIRALDTECT II Multiplex real time G2M2001 Domestic
RT-PCR for COVID-19
78 Genes 2 Me Private Limited VIRALDTECT Multiplex Real-Time G2M1001 Domestic
PCR kit
79 Genestore India Private Limited, Detection Direct 2 Gene SARS-CoV-2 GSIN.M.K.48 Domestic
Gurgaon rRT-PCR Detection Assay (Genestore
France)
80 Genestore India Private Limited, DETECTION EXPERT SARS COV - GSIN MK80 Domestic
Gurgaon 2 rRT-PCR DETECTION ASSAY
81 Genestore India Private Limited, Detection Expert SARS-CoV-2rRT- GSIN.M.K.63 Domestic
Gurgaon PCR Detection Assay (Genestore
France)
82 Genestore, France Detection Expert 1S © SARS CoV-2 DII.31519.3.0000 Imported
One Step rRT-PCR Kit 001
83 Genesystem Co., Ltd, South Korea SMARTCHEK Novel Coronavirus SC-ZA310A-C- Imported
(Genetix Biotech Asia Pvt Ltd) (SARS-CoV-2) Detection Kit 100
84 Genetix Biotech Asia Pvt Ltd, New CoviNAT-Novel Coronavirus (SARS- GX-CA13AQ-C- Domestic
Delhi CoV-2) Detection Kit 100
85 Genetix Biotech Asia Pvt Ltd, New COVI-quick (COVID-19 Real Time CQH21I01 Domestic
Delhi PCR Kit)
86 Genetix Biotech Asia Pvt Ltd, New COVISure (Lyo Mix) COVID19 Real PDT1T20.I.301 Domestic
Delhi Time PCR Kit
87 Genetix Biotech Asia Pvt Ltd, New COVISure (version 2.0) COVID19 CWZ.1T20.I.301 Domestic
Delhi Real Time PCR Kit
88 Genetix Biotech Asia Pvt Ltd, New COVISure COVID-19 Real Time PCR G1T20.G.101 Domestic
Delhi Kit
89 Genetix Biotech Asia Pvt Ltd, New CoviSure Media Direct Extraction CMD21I01 Domestic
Delhi (Covid-19 Real Time Pcr Kit)
90 Genetix Biotech Asia Pvt Ltd, New CoviSure Media Direct Extraction CMD21I02 Domestic
Delhi (Covid-19 Real Time Pcr Kit)-100
Tests
91 Genome Diagnostics Pvt. Ltd., New GenosensnCOV 2019 Real time PCR CoV-002/20 Domestic
Delhi, India kit
92 Genores Biotech Pvt Ltd, Maharashtra, GenoCoV G/GC/20/0006 Domestic
India
93 Gland Pharma Ltd., Hyderabad RT PCR SARS-CoV-2 20200406 Domestic
94 Guangdong Ardent Biomed Co., Ltd, Novel Coronavirus (COVID-19) V20200609 Imported
Hong Kong (Biotime Healthcare Private Nucleic Acid Detection Kit (PCR-
Limited) Fluorescent Probe)
95 HA Tech Biopharma& Diagnostics, SARS-CoV-2 RT-PCR Multiplex NAT-01-200901 Imported
Australia (RLT Group Services) Diagnostic Kit
96 Helini Biomolecules, Chennai Helini Coronavirus Real-Time PCR kit 01/2020, 02/2020, Domestic
[RdRp& ORF gene – Dual target- 03/2020
single tube assay]
97 Helini Biomolecules, Chennai, India Helini Coronavirus [COVID-19] Real 01-01-2020 Domestic
time-PCR Kit MFD: 04/20
98 HiMedia Laboratories Private Limited, Hi-PCR® Covid-19 Detection Kit 492367 Domestic
Mumbai (Dry Swab Method)
99 HiMedia Laboratories Pvt. Ltd Hi-PCR COVID-19 Triplex Probe 0000494939 Domestic
PCR Kit
100 Himedia Laboratories Pvt. Ltd., Hi-PCR® Coronavirus (COVID-19) 453574 Domestic
Multiplex Probe PCR Kit
101 HuwelLifesciencesPvt. Ltd., Hyderabad, Quantiplus Multiplex COVID-19 QLCNM0120.2 Domestic
India detection kit
102 HuwelLifesciencesPvt. Ltd., Hyderabad, QuantiplusCoV detection KIT Ver 2.0 QLCNV0620 Domestic
India QLCNV0920
103 Indian Institute of Technology, Delhi, Covid 19 Probe-free Real Time PCR 9042020 Domestic
India Diagnostic Kit
104 INDO-MIM PRIVATE LIMITED RT PCR Kit SARS CoV2 RTPI -01-TB-001 Domestic
105 InnoDx Solutions Pvt. Ltd InnoDetect COVID-19 RT-PCR kit COV-21-JU-20 Domestic
Version 1
106 iNtRON Biotechnology, Inc., Korea LiliF COVID-19 Multi Real-time RT- H215060553 Imported
(Loften India Pvt Ltd) PCR Kit
107 Intron Biotechnology, Korea (Loften LiliF COVID-19 Reqal Time RT-PCR H215051153 Imported
India Pvt Ltd) kit RPCR200402
108 Jeev Diagnostics Pvt. Ltd identi SARS CoV-2 G2 RT PCR KIT RPB2107 Domestic
109 JITM Skills Private Limited, New Delhi, JITM COVID-19 Detection Kit JJ15052003 Domestic
India
110 JN Medsys Pte Ltd, Singapore Protect COVID-19 RT-qPCR Kit RD 202004-001 Imported
111 Karwa Enterprises Private Limited, Karwa COVID-19 RT LAMP RTL607211 Domestic
Delhi Diagnostic Kit
112 Karwa Enterprises Private Limited, Karwa SARS-CoV-2 Nucleic Acid 20200213 Domestic
Delhi Detection Kit
113 KILPEST (3B BlackBio Biotech India TRUPCR SARS-CoV-2RT-qPCR kit CoV- Domestic
Ltd., Bhopal, India) version 2 19/V2/2020/01
114 Kogene Biotech Co. Ltd, Seoul, Korea Powercheck SARS CoV-2 RT PCR 1R6902200602 Imported
(Kin Diagnostics) Kit
115 Kogene Biotech, Seoul, Korea Power Check 2019 nCoV Real Time R6900TD200423 Imported
PCR Kit
116 Lab Care Diagnostics (India) Pvt. Ltd., Accucare COVID-19 One-step RT- RPCR200401 Domestic
Mumbai, India pCR kit
117 Lab Genomics Co Ltd, Republic of LabGun COVID-19 Assay plus CVA 20E001 Imported
Korea (Siemens Healthcare Private
Limited)
118 Lab Genomics Co Ltd, Republic of LabGun Real Time PCR Kit COV20D001 Imported
Korea (Siemens Healthcare Private COV20D002
Limited) COV20D004
COV20D006
119 Lab Genomics Co Ltd, Republic of LabGun™ COVID-19 ExoFast RT- CVF20G001 Imported
Korea (Siemens Healthcare Private PCR Kit
Limited)
120 Lifespan Biotech Pvt Ltd, Madhya LS COVID-19 RT-qPCR kit VLC20002 Domestic
Pradesh, India
121 Lifespan Biotech Pvt Ltd, Madhya LS COVID-19 RT-qPCR Multiplex LSMX20200621 Domestic
Pradesh, India Kit
122 Lipomic Healthcare Pvt. Ltd., New Lipomic COVID-19 multiplex LIPO-001 Domestic
Delhi RealtimeRT-PCR Kit
123 LLC Art Biotech Art Test COVID-19 kit C19300320 Domestic
124 M.J.BiopharmPvt. Ltd MJ Coronavirus (COVID-19) RT- RTPCR0520AB2 Domestic
qPCR Kit 1
125 M/s Siemens Healthcare Private IMDX SARS-CoV-2 Multiplex 90030721 Domestic
Limited, Mumbai ORF1ab/N gene RTPCR assay
126 Maccura Biotechnology Co Ltd China SARS-CoV-2 Nucleic Acid Detection 420131 Imported
(Eris Lifesciences Ltd) Kit (Flourescent PCR)
127 MagGenome Technologies Pvt. Ltd, MagGenome COVID-19 single Tube RTPCR001 Domestic
Emakulam Multiplex RT-PCR Kit
128 Med Achievers Private Limited, Noida, Genome Analyst SARS-CoV-2 Lot No. GA0306- Domestic
Uttar Pradesh, India detection kit 20-A, Batch No.
MGA202003006
129 Medical and Biological Laboratories MEBRIGHT SARS-CoV-2 Kit 01FA Imported
(MBL) Co. Ltd, Japan (OSB Agencies
Pvt Ltd)
130 Medsource Ozone Biomedicals, COVID-19 RT-PCR kit 20200433 Domestic
Faridabad, Haryana
131 Medsource Ozone Biomedicals, OZOFIND SARS COV2 RT PCR KIT TLPCOV040920 Domestic
Faridabad, Haryana
132 Meril Diagnostics Pvt Ltd, Gujarat, Meril COVID-19 One-step RT-PCR MRD091 Domestic
India Kit MRD097
MRD098
M1052007
133 Meril Diagnostics Pvt Ltd, Gujarat, One-Step COVID-19 RT-PCR Kit MB20009 Domestic
India (Lyophilized)
134 Meril Diagnostics Pvt Ltd, Gujarat, One-Step COVID-19 RT-PCR Kit MB20008 Domestic
India (Lyophilized) (Target ORF1ab and N
genes)
135 MetaDesign Solutions Pvt Ltd, Haryana Pathkits MDS COVID Detect RTPCR MDS/PCR/COV/ Domestic
Kit 11/20
136 Mico Biomed Co., Ltd Veri-Q COVID-19 Multiplex M2243a21CN1Z Domestic
Detection Kit A
137 Micobiomed Co. Ltd, Korea (POCT Veri-Q COVID-19 Multiplex M2243a20DN1F Imported
Services Pvt Ltd) Detection Kit A
138 Micobiomed Co. Ltd, Korea (POCT Veri-Q nCOV-QM COVID-19 M224320EN1HB Imported
Services Pvt Ltd) Multiplex Detection Kit
139 Microbio PTY Ltd, Australia (Bizsoch Microbio-InfectID-SARS-COV-19 MB-INF00001 Imported
Consultants LLP) (Cat#:MB-1)
140 Mylab Discovery Solutions Pvt. Ltd. CoviSwiftTM COVID-19 S Plus CP00007-C- Domestic
Rapid PCR Kit (POCT) 0122001-3
141 Mylab Discovery Solutions Pvt. Ltd. Patho Detect PP00005-C- Domestic
0320001
PP00005-C-
0420001
PP00005-C-
0320002
PP00005-C-
0420002
142 Mylab Discovery Solutions Pvt. Ltd. Pathodetect (Two tube assay) PP00005-C- Domestic
0520003
143 Mylab Discovery Solutions Pvt. Ltd. Pathodetect Coronavirus (COVID-19) PP00005-C- Domestic
Qualitative PCR Kit 070001E
144 Mylab Discovery Solutions Pvt. Ltd. TruemixCovid 19 ETMXCD01 Domestic
145 Nanjing Vazyme Medical Technology 2019-Novel Coronavirus (2019-nCoV) 7E40110 Imported
Co. Ltd, China (BIOTIME Healthcare Triplex RT-qPCR Detection Kit
Pvt. Ltd.)
146 NeoDx Biotech Labs Private Limited, CoviDx Assure SARS-CoV-2 RT-PCR CDA3NR20111 Domestic
India Detection Kit
147 NeoDx Biotech Labs Private Limited, CoviDx Detect SARS-CoV-2 RT-PCR CDD3NR20111 Domestic
India Detection Kit
148 NeoDx Biotech Labs Private Limited, CoviDX Direct Plex SARS-CoV-2 CM4D-21061 Domestic
India RT-PCR Detection Kit
149 NeoDx Biotech Labs Private Limited, CoviDx mPlex-3NC SARS-CoV-2 CM3NC-140820 Domestic
India RT-PCR Detection Kit
150 NeoDx Biotech Labs Private Limited, CoviDxTM mPlex-3NR SARS-CoV-2 CM3NR-120820 Domestic
India RT-PCR Detection Kit
151 NeoDx Biotech Labs Private Limited, CoviDx mPlex-4R SARS-CoV-2 RT- CM4R-030820 Domestic
India (DSS Imagetech Pvt Ltd) PCR Detection Kit
152 NextGenInvitro Diagnostics Pvt COVSCAN-RT-qPCR Kit CVSCNqPCR102 Domestic
Ltd,Haryana 0_1
153 Ningbo Health Gene Technologies Co., SARS-CoV-2 Virus detection 200522006 Imported
Ltd. (The Rising Medicare Private Diagnostic Kit (RT-qPCR Method)
Limited) Version 1.0
154 NovaTecImmunodiagnostica, Germany GSD NovaPrime SARS-COV-2 PCOV6030- Imported
(Eurofins Amar Immunodiagnostics Pvt. (COVID-19) RT-PCR 005G,
Ltd) PCOV6030-005-
1, PCOV6030-
006
155 Nucleus Diagnosys LLP, Gujarat, India SARS CoV-2 Triplex PCR Kit RD2762001 Domestic
156 OSANG Health Care, South Korea Gene Finder COVID-19 2003-R45-22 Imported
157 Oscar Medicare Pvt. Ltd., New Delhi, COVID-19 RT-PCR Kit OSCOV-003 Domestic
India Catalog No.
OSCOV-96
158 Perkin Elmer, Finalnd SARS-CoV-2 RT-qPCR Reagent Kit 680613 Imported
680415
680694
159 PishtazTebZaman Diagnostics, Iran COVID-19 One-step RT-PCR kit 99001 Imported
(Corevyan Private limited)
160 POCT Services Private Limited Q-Line Molecular ER nCOV-19 RT- M200702 Domestic
PCR Kit
161 POCT Services Pvt. Limited, Lucknow, Q-line Molecular Coronavirus P200401 Domestic
India (COVID-19) RT-PCR kit
162 Poly Medicure Limited, Faridabad, POLYMED Q 2019 nCoV RT PCR 44317 Domestic
Haryana Kit
163 Primer Design, UK Z-Path Covid-19C (Genesig) JN-02780-0011 Imported
164 Progenie Molecular , Spain RealCycler Coronavirus SARS-CoV-2 RC1405 Imported
(CliniExperts Services Private Limited, (ORF8+ E gene)
New Delhi)
165 Promea Therapeutics, Telangana ProPCR COVID-19 RT-qPCR TRCV 2001 Domestic
166 QRX Private Limited, Delhi SaralTest SARS-CoV-2-RT LAMP Kit COVLAMP06210 Domestic
01A
167 QuantuMdx, United Kingdom (Ally-Bio QuantuMDx SARS-CoV-2 RT PCR P01090 Imported
Private Limited) Detection Assay
168 Reliance Industries Limited, India ‘R-Green Kit (SARS CoV-2 realtime 44228 Domestic
PCR)
169 Reliance Industries Limited, India R-Green PRO-one: Taqman based 44201 Domestic
real-time PCR Kit
170 Roche Diagnostics, Switzerland Light Mix Modular SARS-CoV-2 48492015 Imported
(COVID19) RdRp
171 Sansure Biotech Inc., Changsha, China Novel Coronavirus(2019-nCoV) 2020029/S3102E Imported
Nucleic Acid Diagnostic Kit (PCR-
Fluorescence Probing)
172 SD Biosensor, South Korea nCoV Real-Time Detection kit MNCO 0120004 Imported
MNCO0120009
173 Seegene, South Korea Allplex 2019-nCoV assay RP4520A01 Imported
RP4520D34
RP4520D47
RP4520D50
RP4520D51
RP4529D70
174 SeegeneInc, South Korea Allplex SARS-CoV-2 Master Assay RVA321C02 Imported
175 Sentinel Diagnostics, Italy STAT-NAT COVID-19 B Realtime 00310 Imported
RT-PCR Kit 00324
00365
176 Sentinel Diagnostics, Italy (Kopran STAT NAT COVID-19 HK 420 Imported
Laboratories Limited) (Lyophilized mix for qualitative
detection of Novel Corona virus SARS
CoV-2 in Realtime RT-PCR)
177 Shambhav Medical, Uttar Pradesh ViroDetect COVID-19 Real-Time 95001001 Domestic
PCR Kit
178 Shanghai ZJ Bio-Tech Co., Ltd (Life LifeRiver Novel Coronavirus (2019- 20200601 Imported
Technologies (India) Pvt Ltd) nCoV) Real Time Multiplex RT-PCR
Kit
179 Shankaranarayana Life Sciences LLP, SN CoV Ensure One Step Multiplex SNR220211S1 Domestic
Karnataka SARS CoV-2 RT-PCR Detection Kit
180 ShenzenUni-Medica Technology Co. Real Time PCR Kit for Novel 20200602 Imported
Ltd (Vishat Diagnostics Pvt Ltd) Coronavirus 2019-nCoV (ORF1ab, N)
181 Sidak Life Care Pvt Ltd., Haryana, India MP RT-PCR Kit – Real Time PCR Kit SLC/RT- Domestic
for COVID-19 RNA PCR/0011/20
182 Siemens Healthcare Private Limited, IMDX SARS-CoV-2 Multiplex E/N 90010721 Domestic
Vadodara, India gene RTPCR assay
183 SNP Biotechnology R&D Ltd, Turkey COVID-19 Real Time PCR kit v1 2006R2 Imported
(Wockhardt Ltd)
184 SreeChitraTirunal Institute for Medical Chitra SARS CoV2 Multiplex RT- SCT-COV-12894 Domestic
Sciences and Technology, Kerala PCR kit
185 Stellence Pharmsciences Pvt Ltd Stellence Covid-19 RT-qPCR Kit 27032 Domestic
186 Tata Medical and Diagnostics Ltd TATA MD CHECK RT-PCR XF CM4D-21072 Domestic
187 Tata Medical and Diagnostics Ltd TATA MD CHECK RT-PCR XF CM4D-21073 Domestic
188 Tata Medical and Diagnostics Ltd TATA MD CHECK RT-PCR 3 GENE K014-V001 Domestic
189 Tata Medical and Diagnostics Ltd TATA MD CHECK RT-PCR FAST K022-V001 Domestic
190 Tata Medical and Diagnostics Ltd TATA MD CHECK RT-PCR FAST 3 K021-V001 Domestic
GENE
191 Tata Medical and Diagnostics Ltd TATA MD CHECK RT-PCR FLEX K015-V001 Domestic
192 TCM Limited, Kerala Covi-Detect -2 Real Time PCR 210502 Domestic
Detection Kit
193 Theragen Biologics Private Limited, GEN-COV Corona Virus Single Tube TBL20001 Domestic
Tamil Nadu Multiplex RT-PCR Detection kit
194 Thermo Fisher Scientific, US CoviPathCovid 19 RT PCR Kit I1-7-07-00-14 Imported
(Invitrogen Bioservices India Pvt Ltd) (A50780)
195 Transasia Diagnostics Solutions ErbaMDx COVID-19 RT PCR Kit 2031503-TDPL Domestic
Limited, Maharashtra
196 TranScience Innovative Technologies, TrueScreen COVID-19 Multiplex Real TS0820-01 Domestic
Chennai Time PCR Detection Kit
197 Trivitron healthcare Pvt Ltd COVIDsure Multiplex Realtime RT- COVID-C-T-004 Domestic
PCR kit
198 Trivitron healthcare Pvt Ltd Covidsure Pro Multiplex RT-PCR kit COVID-M-001 Domestic
199 Trivitron Healthcare Pvt. Ltd COVIDsure Direct Multiplex RT PCR CVDSRD122101 Domestic
with extraction free technology A
200 Tulip mDiagnostics (P) Ltd., Verna AMPLICHAIN SARS-CoV-2 ZRD/21/K-32 Domestic
201 uBio Biotechnology Systems Private ViraGEN Molecular Diagnostics UBMD0072001 Domestic
Limited Covid-19 Real- Time RT-PCR kit
202 Vimek Bioconcept Pvt Ltd SARS-CoV-2 Fluorescent PCR COVPCR211101 Domestic
203 Vitane Biologics Pvt Ltd, Telangana CovTect COVID-19 Qualitative PCR VBRT004 Domestic
Kit
204 Vitro S.A., Spain (DSS Imagetech SARS-CoV-2 RT-PCR Kit COVP006 Imported
Private Ltd.)
205 Vitromed Healthcare VITROMED Q 2019 nCoV RT PCR VF2120163 Domestic
Kit
206 Wuhan Easy Diagnosis Biomedicine Co. COVID-19 (SARS-CoV-2) Nucleic 200401HW Imported
Ltd acid test kit
207 Yaathum Biotech Private Limited, Tamil SARS COV-2 qPCR Multiplex Kit Y0013-102020- Domestic
Nadu, India 0001
208 Yashraj Biotechnology Limited CoviGene COVID-19 RT-PCR, DCRT0003/21 Domestic
Qualitative Nucleic Acid Test
209 YD Diagnostics Corp., Korea (POCT MolecuTech Real time COVID-19 M2042011 Imported
Services Private Limited) RT-PCR kit
210 YOUSEQ, UK COVID19 E,N,RdRp& S gene YSM1641 Imported
Multiplex qPCR kit
211 ZyBioInc, China Zybio SARS-CoV-2 NA detection kit 200201 Imported
(Biodx healthcare)

*Above listed kits are validated with the mentioned batch number only. The tests have been
performed as per the manufacturer’s instructions. Responsibility for batch to batch consistency lies
with the manufacturer.
Real-Time PCR kits which are US-FDA can be used directly after due marketing approval from
DCGI. The complete list of US-FDA SARS-CoV-2 real time PCR kits is available at
(https://www.finddx.org/covid-19/pipeline/).

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