Professional Documents
Culture Documents
List of Approved Immunoassay Test Kits For Commercial Use
List of Approved Immunoassay Test Kits For Commercial Use
List of Approved Immunoassay Test Kits For Commercial Use
Department of Health
FOOD AND DRUG ADMINISTRATION
1 DIAGNOSTIC KIT FOR NOVEL Bioscience (Chongqing) Diagnostic Technology Co., Ltd – 2-
CORONAVIRUS (2019-nCoV) IgM ANTIBODY 4/F Building 2, No.5 Gangcheng Donghuan Road, Jiangbei
(MAGNETIC PARTICLE CLIA) District, Chongqing, China
2 DIAGNOSTIC KIT FOR NOVEL Bioscience (Chongqing) Diagnostic Technology Co., Ltd – 2-
CORONAVIRUS (2019-nCoV) IgG ANTIBODY 4/F Building 2, No.5 Gangcheng Donghuan Road, Jiangbei
(MAGNETIC PARTICLE CLIA) District, Chongqing, China
3 MAGLUMI 2019-nCoV IgM (CLIA) Shenzhen New Industries Biomedical Engineering Co., Ltd. –
No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen,
P.R. China
4 MAGLUMI 2019-nCoV IgG (CLIA) Shenzhen New Industries Biomedical Engineering Co., Ltd. –
No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen,
P.R. China
5 Camtech COVID-19 IgM/IgG (CAMTECH- Camtech Biomedical Pte Ltd- 217 Henderson Road, #03-08,
LFART) Singapore
6 SARS-CoV-2 IgG ASSAY Abbott Ireland- Diagnostics Division, Finisklin Business Park,
Sligo, Ireland
11 VITROS Immunodiagnostic Products Anti-SARS- Ortho-Clinical Diagnostics, Inc.-100 Indigo Creek Drive-
CoV-2 IgG Rochester, NY 14626, USA
Reagent Pack used in combination with the
VITROS Immunodiagnostic Products Anti-SARS-
CoV-2 IgG Calibrator
18 SARS-CoV-2 IgG ASSAY FOR ALINITY Abbott Ireland- Diagnostics Division, Finisklin Business Park,
INSTRUMENT Sligo, Ireland
24 SARS-COV-2 IgG (Electrochemiluminescence Shenzhen Lifotronic Technology Co., Ltd.- Unit A, 4th Floor,
Immunoassay) Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan
District, 518055, Shenzhen City, Guangdong Province, P. R.
China
25 SARS-COV-2 IgM (Electrochemiluminescence Shenzhen Lifotronic Technology Co., Ltd.- Unit A, 4th Floor,
Immunoassay) Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan
District, 518055, Shenzhen City, Guangdong Province, P. R.
China
26 SuperFlex Anti-SARS-CoV-2 Ab Kit Suzhou Sym-Bio Lifescience Co., Ltd. – No.115, North Tai
Ping Road, Taicang Economic Development Zone, Jiangsu
Province, 215400, China
27 SuperFlex Anti-SARS-CoV-2 IgG Kit Suzhou Sym-Bio Lifescience Co., Ltd. – No.115, North Tai
Ping Road, Taicang Economic Development Zone, Jiangsu
Province, 215400, China
28 SuperFlex Anti-SARS-CoV-2 IgM Kit Suzhou Sym-Bio Lifescience Co., Ltd. – No.115, North Tai
Ping Road, Taicang Economic Development Zone, Jiangsu
Province, 215400, China
29 Platelia SARS-CoV-2 Total Ab assay Bio-Rad Laboratories -3, boulevard Raymond Poincaré 92430
Marnes-la-Coquette - France
34 COVID-19 IgM/IgG Antibody Test Artron Laboratories Inc. – 3938 North Fraser Way Burnaby,
B.C. V5J 5H6, Canada
36 Dimension EXL SARS-CoV-2 Total antibody Siemens Healthcare Diagnostics Inc. – 500 GBC Drive
assay (CV2T) Newark, DE 19714, USA
37 ENZY-WELL SARS-CoV-2 IgM DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10, 53035
Monteriggioni (Siena) Italy
38 ENZY-WELL SARS-CoV-2 IgA DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10, 53035
Monteriggioni (Siena) Italy
39 COVID-19 IgG Antibody ELISA Test Kit Beijing Kewei Clinical Diagnostic Reagent Inc – No. 7, Yan Qi
He Xi Yi Rd. Huairou District 101407, Beijing, China
40 COVID-19 IgM Antibody ELISA Test Kit Beijing Kewei Clinical Diagnostic Reagent Inc – No. 7, Yan Qi
He Xi Yi Rd. Huairou District 101407, Beijing, China
41 COVID-19) IgM/IgG Test Kit (Dry Fluorescence Lansion Biotechnology Co., Ltd.- F3, building 1, No. 8, Keling
Immunoassay) (NL-CA002-2020-50668) Road, High-Tech District, 215000 Suzhou, Jiangsu Province
People's Republic, China
43 ENZY-WELL SARS-CoV-2 IgG DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10, 53035
Monteriggioni (Siena) Italy
44 SCoV-2 Detect IgG ELISA InBios International Inc. – 307 Westlake Ave North Suite 300,
Seattle, WA 98109, United States
45 ATELLICA IM SARS-CoV-2 TOTAL (COV2T) Siemens Healthcare Diagnostics Inc. – 511 Benedict Avenue,
Tarrytown, NY, 10591, USA
46 ADVIA Centaur SARS-CoV-2 Total (COV2T) Siemens Healthcare Diagnostics Inc. – 511 Benedict Avenue,
Tarrytown, NY, 10591, USA
49 WANTAI SARS-CoV-2 Ab ELISA Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. – 31
Kexueyuan Road, Changping District Beijing, People’s
Republic of China
50 WANTAI SARS-CoV-2 IgM ELISA Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. – 31
Kexueyuan Road, Changping District Beijing, People’s
Republic of China
51 SCoV-2 Detect IgM ELISA InBios International Inc. – 307 Westlake Ave North Suite 300,
Seattle, WA 98109, United States
52 Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit Diazyme Laboratories, Inc – 12889 Gregg Court Poway, CA
92064 USA
53 GenScript SARS-CoV-2 Neutralization Antibody Genscript Biotech (Singapore) Pte Ltd – 1 Fusionopolis Place,
Detection Kit #03-20 Galaxis, Singapore
54 2019-nCov IgG Antibody Kit Dynamiker Biotechnology (Tianjin) Co., Ltd. – No. 14
(Chemiluminescence) Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-
Singapore Tianjin Eco-City, 300467 Tianjin, China
55 2019-nCov IgM Antibody Kit Dynamiker Biotechnology (Tianjin) Co., Ltd. – No. 14
(Chemiluminescence) Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-
Singapore Tianjin Eco-City, 300467 Tianjin, China
56 ADVIA Centaur SARS-CoV-2 IgG (COV2G) Siemens Healthcare Diagnostics Inc. – 511 Benedict Avenue,
Tarrytown, NY 10591, USA
57 Atellica IM SARS-CoV-2 IgG (COV2G) Siemens Healthcare Diagnostics Inc. – 511 Benedict Avenue,
Tarrytown, NY 10591, USA
58 Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit Diazyme Laboratories, Inc – 12889 Gregg Court Poway, CA
92064 USA
59 ACCEL ELISA COVID-19 Plexence, Inc. – 1-1301, 1302, 1303, 16-4, Dongbaekjungang-
ro, 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do 17015,
Korea
60 ACCESS SARS-CoV-2 IgG Beckman Coulter, Inc. –250 S. Kraemer Boulevard, Brea CA
92821, USA
61 ACCESS SARS-CoV-2 IgM Beckman Coulter, Inc. –250 S. Kraemer Boulevard, Brea CA
92821, USA
62 Elecsys Anti-SARS-CoV-2 S (Material Code: Roche Diagnostics GmbH, – Sandhofer Strasse 116, D-
09289267190) 68305 Mannheim, Germany
63 Elecsys Anti-SARS-CoV-2 S (Material Code: Roche Diagnostics GmbH, – Sandhofer Strasse 116, D-
09289275190) 68305 Mannheim, Germany
65 CalSet Anti‑SARS‑CoV‑2 S (Material Code: Roche Diagnostics GmbH, – Sandhofer Strasse 116, D-68305
09289291190 Mannheim, Germany
66 Kit for the detection of class G ALLEL LLC – Tvardosky Street 8 Moscow, Russia
immunoglobulins (IgG) to the SARS-CoV-2
coronavirus by the enzyme immunoassay
"SARS-CoV-2-IgG-ELISA"
67 DiaSorin LIAISON SARS-CoV-2 IgM Assay Diasorin S.p.A-Via Crescentino SNC, 13040 Saluggia (VC) -
13040 Saluggia (VC) - Italy
68 SARS-CoV-2 S-RBD IgG (CLIA) Shenzhen New Industries Biomedical Engineering Co., Ltd. –
Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R.
China
69 SARS-CoV-2 Neutralizing Antibodies Test Lansion Biotechnology Co., Ltd. – No.2, Qiande Road,
Kit (Dry Fluorescence Immunoassay) Jiangning District, Nanjing, China
(Specimens: Human Serum, Plasma)
70 Anti-SARS-CoV-2 Neutralizing Antibody Shenzhen Landwind Biotechnology Co., Ltd – 6F, Block 10,
ELISA Kit Tong Fuyu Industrial Park, Taoyuan Street, Nanshan District,
Shenzhen, China
72 COVID-19 Neutralizing Antibody Detection by New Gene (Hangzhou) Bioengineering Co., Ltd. –
Kit Room 1606, Floor 16, Building No. 5, Changhe Street,
Hangzhou, Zhejiang, P.R China