Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

List of Approved Immunoassay Test Kits for Commercial Use

as of 26 MARCH 2021

NO. PRODUCT NAME MANUFACTURER

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

7 LIAISON® SARS-CoV-2 S1/S2 IgG

Diasorin S.p.A-Via Crescentino SNC, 13040 Saluggia (VC) -
Italy

8 Elecsys Anti-SARS-CoV-2 (200 tests, for use in

cobas e 411, e 601, e 602) MAT CODE: Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-68305
09203095190 Mannheim, Germany

9 Elecsys Anti-SARS-CoV-2 (300 tests, for use in

cobas e 801) Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-68305
Mat Code: 09203079190 Mannheim, Germany

10 VITROS IMMUNODIAGNOSTIC PRODUCTS Ortho-Clinical Diagnostics- Felindre Meadows Pencoed,

Anti-SARS-CoV-2 TOTAL REAGENT PACK Bridgend, CF35 5PZ, United Kingdom
USED IN COMBINATION WITH THE VITROS

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

IMMUNODIAGNOSTIC PRODUCTS Anti-

SARS-CoV-2 TOTAL CALIBRATOR

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

12 COVID-19 IgG CONFIRMATION Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 –

Sesto San Giovanni (MI) – Italy

13 COVID-19 IgA Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 –

Sesto San Giovanni (MI) – Italy

14 COVID-19 IgG Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 –

Sesto San Giovanni (MI) – Italy

15 COVID-19 IgM Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 –

Sesto San Giovanni (MI) – Italy

16 ichromaTM COVID-19 Ab Boditech Med Incorporated- 43, Geodudanji 1-gil, Dongnae-

myeon,- Chuncheon-si, Gang-won-do, 24398Republic of Korea

17 AFIAS COVID-19 Ab Boditech Med Incorporated- 43, Geodudanji 1-gil, Dongnae-

myeon,- Chuncheon-si, Gang-won-do, 24398Republic of Korea

18 SARS-CoV-2 IgG ASSAY FOR ALINITY Abbott Ireland- Diagnostics Division, Finisklin Business Park,
INSTRUMENT Sligo, Ireland

19 SARS-CoV-2 IgG (CLIA) Shenzhen Mindray Bio-Medical Electronics Co-Ltd– Mindray

Building Keji l2th Road South, Hitech Industrial Park,
Nanshan, Shenzhen, People’s Republic China

20 Shenzhen Mindray Bio-Medical Electronics Co-Ltd– Mindray

SARS-CoV-2 IgM (CLIA) Building Keji l2th Road South, Hitech Industrial Park,
Nanshan, Shenzhen, People’s Republic China

21 GA CoV-2 IgM GA Generic Assays GmbH - Ludwig-Erhard-Ring 3, 15827

Dahlewitz, Germany

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

22 GA CoV-2 IgG GA Generic Assays GmbH - Ludwig-Erhard-Ring 3, 15827

Dahlewitz, Germany

23 GA CoV-2 IgG+ GA Generic Assays GmbH - Ludwig-Erhard-Ring 3, 15827

Dahlewitz, Germany

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

30 COVID-19 (SARS-CoV-2) IgG ELISA Demeditec Diagnostics GmbH. – Lise-Meitner-Strasse 2, 24145

Kiel, Germany

31 COVID-19 (SARS-CoV-2) IgA ELISA Demeditec Diagnostics GmbH. – Lise-Meitner-Strasse 2, 24145

Kiel, Germany

32 COVID-19 (SARS-CoV-2) IgM ELISA Demeditec Diagnostics GmbH. – Lise-Meitner-Strasse 2, 24145

Kiel, Germany

33 PreciControl Anti-SARS-CoV-2 Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-68305

Mannheim, Germany

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

34 COVID-19 IgM/IgG Antibody Test Artron Laboratories Inc. – 3938 North Fraser Way Burnaby,
B.C. V5J 5H6, Canada

35 Anti-SARS-CoV-2 ELISA (IgA) EUROIMMUN Medizinische Labordiagnostika AG – Seekamp

31 23560 Lubeck, Germany

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

42 Anti-SARS-CoV-2 ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG. –

Seekamp 31 23560 Lubeck, Germany

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

47 VIDAS® SARS-COV-2 IgM BioMérieux SA-376 Chemin de l'Orme, 69280 Marcy-l’Etoile -

France

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

48 VIDAS® SARS-COV-2 IgG BioMérieux SA-376 Chemin de l'Orme, 69280 Marcy-l’Etoile -

France

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

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

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

64 PreciControl Anti‑SARS‑CoV‑2 S (Material Roche Diagnostics GmbH, – Sandhofer Strasse 116, D-

Code: 09289313190) 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

71 Neutralizing Antibody of SARS-CoV-2 Test Anbio (Xiamen) Biotechnology Co., Ltd. –

(Fluorescence Immunochromatographic No.2016,Wengjiao West Road, Xinyang Street, Haicang
Assay) District, Xiamen, Fujian, China

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

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

73 Dynamiker SARS-Cov-2 Neutralization Dynamiker Biotechnology (Tianjin) Co., Ltd. – No. 14

Antibody ELISA Assay (Specimens: Human
serum and plasma
* Updated list in yellow highlights
Building, Eco-Business Park, 2018 Zhongtian Avenue,
Sino-Singapore Tianjin Eco-City, 300467 Tianjin, China
Dynamiker Biotechnology (Tianjin) Co., Ltd. – No. 14
Building, Eco-Business Park, 2018 Zhongtian Avenue,
Sino-Singapore Tianjin Eco-City, 300467 Tianjin, China

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph