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Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

List of COVID-19 Serologic Test Kits (Rapid, Immunoassays)


as of 14 MAY 2020, 4:00PM

NO. PRODUCT NAME MANUFACTURER

1 NANJING VAZYME 2019-nCoV Biolidics Limited. – 37 Jalan Pemimpin, #02-07,


IgG/IgM DETECTION KIT Mapex, Singapore

2 NOVEL CORONAVIRUS (2019-


NCOV) IgM/IgG ANTIBODY Nanjing Vazyme Medical Technology Co., Ltd – Level
DETECTION KIT (COLLOIDAL 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang
GOLD METHOD) Road, Nanjing China

3 DIAGNOSTIC KIT FOR IgM/IgG Zhuhai Livzon Diagnostic Inc. – 1st Building, No. 266,
ANTIBODY TO CORONAVIRUS Tongchang Road, Xiangzhou District, Zhuhai,
(SARS-CoV-2) (COLLOIDAL GOLD) Guangdong Province, People’s Republic of China

4 Innovita (Tangshan) Biological Technology Co., Ltd. –


2019-nCoV ANTIBODY TEST
No. 699 Juxin Street, High-Tech Industrial
(COLLOIDAL GOLD)
Development Zone, Qian’an 064400, Hebei, China

5 SARS-CoV-2 ANTIBODY TEST Guangzhou Wondfo Biotech Co., Ltd. – No. 8


(LATERAL FLOW METHOD) Lizhishan Road, Science City, Luogang District,
510663, Guangzhou, People’s Republic of China

6 WANTAI SARS- CoV Ab RAPID TEST Beijing Wantai Biological Pharmacy Enterprise Co.,
KIT Ltd. – 31 Kexueyuan Road, Changping District
Beijing, People’s Republic of China

7 Hangzhou Alltest Biotech Co., Ltd. – #550, Yinhai


2019 n-CoV IgG/IgM RAPID TEST
CASSETTE Street, Hangzhou Economy and Technology
Development Area, 310018, Hangzhou, People’s
Republic of 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

NO. PRODUCT NAME MANUFACTURER

8 CTK Biotech, Inc. – 13855 Stowe Dr. Poway


OnSite COVID-19 IgG/IgM Rapid Test
California, USA

9 Qingdao Hightop Biotech Co., Ltd. – No. 369 Hedong


HIGHTOP SARS-CoV-2 IgM/IgG
Road, Hi-tech Industrial Development Zone, 266112
ANTIBODY RAPID TEST
Qingdao, Shandong, Peoples Republic of China

10 Cellex qSARS-CoV-2 IgG/IgM Cassette Cellex, Inc., – 76 TW Alexander Drive, Research


Rapid Test Triangle Park, Durham NC 27709-0002, USA

11 Hangzhou Biotest Biotech Co., Ltd. – 17# Futai Road


COVID-19 IgG/IgM RAPID TEST KIT Zhongtai Street, Yuhang District, Hangzhou, People’s
Republic of China

12 DIAGNOSTIC KIT FOR NOVEL


CORONAVIRUS (2019-nCoV) IgM Bioscience (Chongqing) Diagnostic Technology Co.,
ANTIBODY (MAGNETIC PARTICLE Ltd – 2-4/F Building 2, No.5 Gangcheng Donghuan
CLIA) Road, Jiangbei District, Chongqing, China

13 DIAGNOSTIC KIT FOR NOVEL


CORONAVIRUS (2019-nCoV) IgG Bioscience (Chongqing) Diagnostic Technology Co.,
ANTIBODY (MAGNETIC PARTICLE Ltd – 2-4/F Building 2, No.5 Gangcheng Donghuan
CLIA) Road, Jiangbei District, Chongqing, China

14 Healgen Scientific Limited – Liability Company 3818


COVID-19 IgG/IgM Rapid Test Cassette Fuqua Street Houston, TX 77047, USA

15 Zhejiang Orient Gene Biotech Co., Ltd – 3787#, East


COVID-19 IgG/IgM RAPID TEST Yangguang Avenue, Dipu Street Anji, Huzhou,
CASSETTE 313300, P.R China

16
BIOLIDICS 2019-nCoV IgG/IgM Biolidics Limited. – 37 Jalan Pemimpin, #02-07,
DETECTION KIT Mapex, Singapore

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

NO. PRODUCT NAME MANUFACTURER

17 MAGLUMI 2019-nCoV IgM (CLIA) Shenzhen New Industries Biomedical Engineering Co.,
Ltd. – No.23, Jinxiu East Road, Pingshan District,
518122 Shenzhen, P.R. China

18 MAGLUMI 2019-nCoV IgG (CLIA) Shenzhen New Industries Biomedical Engineering Co.,
Ltd. – No.23, Jinxiu East Road, Pingshan District,
518122 Shenzhen, P.R. China

19 Camtech COVID-19 IgM/IgG Camtech Biomedical Pte Ltd- 217 Henderson Road,
(CAMTECH-LFART) #03-08, Singapore

20 VivaDiag™ COVID-19 IgM/IgG Rapid Vivachek Biotech Hangzhou Co. Ltd. - Level 2, Block
Test 2, 146 East Chaofeng Rd., Yuhang Economy
Development Zone, Hangzhou, 311100, Zhejiang
China

21 Novel Coronavirus (2019-nCoV) Shanghai Outdo Biotech Co., Ltd – 3F Building 2, 3F


Antibody Test Kit (Colloidal Gold) Building 4, 3F Building 5, No. 151 Libing Rd., Pilot
Free Trade Zone, 201203 Shanghai, People’s Republic
of China

22 DPP COVID-19 IgM/IgG System Chembio Diagnostic Systems, Inc. - 3661 Horseblock
Road Medford, NY 11763 USA

23 Abbott Panbio™ COVID-19 lgG/lgM Abbott Rapid Diagnostics Jena GmbH – Orlaweg 1
RAPID TEST DEVICE 07743 Jena, Germany

24 SARS-CoV-2 Antibody Test Beijing Lepu Medical Technology Co., Ltd – 3th Floor
(COLLOIDAL GOLD and 5th Floor Building 7-1 No.37 Chaoqian Road,
IMMUNOCHROMATOGRAPHY) Changping District, Beijing, 102200, P.R. China

25 SARS-CoV-2 IgG ASSAY Abbott Ireland- Diagnostics Division, Finisklin


Business Park, Sligo, Ireland

26 LIAISON® SARS-CoV-2 S1/S2 IgG Diasorin S.p.A-Via Crescentino SNC, 13040 Saluggia
(VC) - Italy

27 COVID-19 IgM Antibody Rapid Test Kit Hecin Scientific, Inc. – 4F Building A, #1 Ruifa Road,
Luogang District, Guangzhou, 510700 P.R 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

NO. PRODUCT NAME MANUFACTURER

28 Elecsys Anti-SARS-CoV-2 (200 tests, for Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-
use in cobas e 411, e 601, e 602) MAT 68305 Mannheim, Germany
CODE: 09203095190

29 "Elecsys Anti-SARS-CoV-2 (300 tests, Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-
for use in cobas e 801) Mat Code: 68305 Mannheim, Germany
09203079190"

30 Diagnostic Kit for SARS-CoV-2 Shanghai Kehua Bio-engineering Co., Ltd – 1189
IgM/IgG Antibody (Colloidal Gold) North Qinzhou Road, Xuhui District, Shanghai,
200233, People’s Republic of China

31 DiagnoSure COVID-19 IgG/ IgM Rapid Hangzhou Biotest Biotech Co., Ltd – #17, Futai Road,
Test Cassette Zhongtai Street, Yuhang District, 311121 Hangzhou,
People’s Republic of China

32 VITROS IMMUNODIAGNOSTIC Ortho-Clinical Diagnostics, Inc.-100 Indigo Creek


PRODUCTS Anti-SARS-CoV-2 TOTAL Drive-Rochester, NY 14626, USA
REAGENT PACK USED IN
COMBINATION WITH THE VITROS
IMMUNODIAGNOSTIC PRODUCTS
Anti-SARS-CoV-2 TOTAL
CALIBRATOR

33 CORONAVIRUS DISEASE 2019 MedicalSystem Biotechnology Co., Ltd.- No. 289,


ANTIBODY (IgM/IgG) RAPID TEST Qiming South Road, Yinzhou District, 315104 Ningbo,
CASSETTE China

34 CLONGENE COVID-19 IgG/IgM Hangzhou Clongene Biotech Co Ltd. – No 1 Yichuang


RAPID TEST CASSETTE Road Yuhang Sub district Yuhang District, Hangzhou,
311121 China

35 Anti-SARS-CoV-2 Rapid Test Autobio Diagnostics Co., Ltd – No. 87, Jingbei Yi Rd,
National Eco &Tech Zone, Zheng zhou, China

36 Platelia SARS-CoV-2 Total Ab assay Bio-Rad Laboratories -3, boulevard Raymond Poincaré
92430 Marnes-la-Coquette - France

37 SARS-COV-2 IgGM/IgG ANTIBODY Zybio, Inc. – Floor 1 to Floor 4, Building 30, No.6 of
ASSAY KIT (COLLOIDAL GOLD Taikang Road, Block C of Jianqiao Industrial Park,
METHOD) Dadukou District, 400082 Chongqing, 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

NO. PRODUCT NAME MANUFACTURER

38 VITROS Immunodiagnostic Products Ortho-Clinical Diagnostics- Felindre Meadows,


Anti-SARS-CoV-2 IgG Pencoed, Bridgend, CF35 5PZ, United Kingdom
Reagent Pack used in combination with
the VITROS Immunodiagnostic Products
Anti-SARS-CoV-2 IgG Calibrator

39 QuickProfile COVID-19 IgG/IgM LumiQuick Diagnostic, Inc.– 2946 Scott Blvd. Santa
Combo Test Card Clara, USA

40 SARS-CoV2(COVID-19) IgG/IgM HangZhou Testsea biotechnology Co.,Ltd– Building 6


Antibody Test (Colloidal Gold) No.8-2 Scien-tech Road , Yuhang Street Hangzhou -
311121,China

41 GenBody COVID-19 IgG/IgM RAPID Genbody Inc.- GenBody Building, 3-18, Eopseong 2-
DIAGNOSTIC TEST gil, Seobuk-gu, Cheonan-si, Chungnam, 31077, Korea

42 2019-nCOV/COVID-19 IgG/IgM Rapid Test Hangzhou Realy Tech Co., Ltd.- 4th floor, #12 Building,
Device Eastern Medicine Town, Xiasha Economic & Technological
Development Area, 310018 Hangzhou, Zhejiang, People’s
Republic of China

43 PCL, Inc. – # 701, 99, Digital-ro 9-gil, Geumcheon-gu,


PCL COVID19 IgG/IgM RAPID GOLD Seoul, 08510, Republic of Korea
* Updated list in yellow highlights

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