Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

List of Approved COVID-19 Rapid Antibody Test Kits

as of 24 April 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

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
* 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