Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

List of Approved Rapid Antibody Test Kits for Commercial Use

as of 26 MARCH 2021

NO. PRODUCT NAME MANUFACTURER

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

2 NOVEL CORONAVIRUS (2019-NCOV) Nanjing Vazyme Medical Technology Co., Ltd – Level 1-3,
IgM/IgG ANTIBODY DETECTION KIT Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing
(COLLOIDAL GOLD METHOD) China

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

4 2019-nCoV ANTIBODY TEST (COLLOIDAL Innovita (Tangshan) Biological Technology Co., Ltd. – No. 699
GOLD) Juxin Street, High-Tech Industrial Development Zone, Qian’an
064400, Hebei, China

5 SARS-CoV-2 ANTIBODY TEST (LATERAL Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road,
FLOW METHOD) Science City, Luogang District, 510663, Guangzhou, People’s
Republic of China

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

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

8 2019 n-CoV IgG/IgM RAPID TEST CASSETTE Hangzhou Alltest Biotech Co., Ltd. – #550, Yinhai Street,
Hangzhou Economy and Technology Development Area,
310018, Hangzhou, People’s Republic of China

9 OnSite COVID-19 IgG/IgM Rapid Test CTK Biotech, Inc. – 13855 Stowe Dr. Poway California, USA

10 HIGHTOP SARS-CoV-2 IgM/IgG ANTIBODY Qingdao Hightop Biotech Co., Ltd. – No. 369 Hedong Road,
RAPID TEST Hi-tech Industrial Development Zone, 266112 Qingdao,
Shandong, Peoples 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

11 Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Cellex, Inc., – 76 TW Alexander Drive, Research Triangle
Test Park, Durham NC 27709-0002, USA

12 COVID-19 IgG/IgM RAPID TEST KIT

Hangzhou Biotest Biotech Co., Ltd. – 17# Futai Road Zhongtai
Street, Yuhang District, Hangzhou, People’s Republic of China

13 COVID-19 IgG/IgM RAPID TEST CASSETTE Healgen Scientific Limited – Liability Company 3818 Fuqua
Street Houston, TX 77047, USA

14 COVID-19 IgG/IgM RAPID TEST CASSETTE Zhejiang Orient Gene Biotech Co., Ltd – 3787#, East
Yangguang Avenue, Dipu Street Anji, Huzhou, 313300, P.R
China

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

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

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

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

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

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

21 CORONAVIRUS DISEASE 2019 ANTIBODY MedicalSystem Biotechnology Co., Ltd.- No. 289, Qiming
(IgM/IgG) RAPID TEST CASSETTE South Road, Yinzhou District, 315104 Ningbo, China

22 CLONGENE COVID-19 IgG/IgM RAPID TEST Hangzhou Clongene Biotech Co Ltd. – No 1 Yichuang Road
CASSETTE Yuhang Sub district Yuhang District, Hangzhou, 311121 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

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

24 Sars Cov-2 IgM/ IgG (Colloidal Gold Method) / Zybio, Inc. – Floor 1 to Floor 4, Building 30, No.6 of Taikang
SARS-COV-2 IGM/IGG ANTIBODY ASSAY Road, Block C of Jianqiao Industrial Park, Dadukou District,
KIT (COLLOIDAL GOLD METHOD) 400082 Chongqing, China

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

26 SARS-CoV2(COVID-19) IgG/IgM Antibody Test HangZhou Testsea biotechnology Co.,Ltd– Building 6 No.8-2
(Colloidal Gold) Scien-tech Road , Yuhang Street Hangzhou -311121,China

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

28 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

29 PCL COVID19 IgG/IgM RAPID GOLD PCL, Inc. – # 701, 99, Digital-ro 9-gil, Geumcheon-gu, Seoul,
08510, Republic of Korea

30 COVID-19 IgG/IgM RAPID TEST CASSETTE Hangzhou Clongene Biotech Co Ltd. – No 1 Yichuang Road
Yuhang Sub district Yuhang District, Hangzhou, 311121 China

31 LYHER Novel Coronavirus (2019-nCoV) Hangzhou Laihe Biotech Co Ltd. – Floor 1 Room 505-512
IgM/IgG Antibody Combo Test Kit (Colloidal Floor, 5 Building B 688 Bin'an Road, Binjiang District,
Gold) Hangzhou, 310052, China

32 COVID-19 IgG/IgM RAPID TEST DEVICE Innovation Science Pty Ltd – 5/25 Stoddart Rd, Prospect, NSW,
2148, Australia

33 SARS-CoV-2 IgG/IgM Rapid Test Zhuhai Encode Medical Engineering Co., Ltd – No. 20,
Honghui 2nd Road, Hongqi Industrial Zone, Jinwan District,
Zhuhai, China

34 COVID-19 IgG/IgM Rapid Test Cassette CHIL TIBBİ MAL. SAN. TİC. LTD. ŞTİ. -10028 sok. No.11
AOSB 35620 Cigli-Izmir/Turkey

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

35 NADAL COVID-19 IgG/IgM Test nal von minden GmbH - Carl-Zeiss-Str. 12, 47445 Moers,
Germany

36 nCOVID-19 IgG&IgM POCT Technogenetics S.r.l. – 15 Corso Vittorio Emanuele II, 20122,
Milano, Italy

37 Rapid 2019-nCOV IgG/IgM Combo Test Card Xiamen Boson Biotech Co., Ltd - 90-94 Tianfeng Road, Jimei
North Industrial Park 361021 Xiamen, Fujian China

38 SARS-CoV-2 IgG/IgM Antibody Test (Colloidal HangZhou Testsea Biotechnology Co., Ltd– Building 6 No.8-2
Gold) Scien-tech Road, Yuhang Street Hangzhou -311121, China

39 SURGITECH COVID-19 IgG/IgM Rapid Test

CTK Biotech, Inc. – 13855 Stowe Dr. Poway California, USA

40 STANDARD™ Q COVID-19 IgG/IgM DUO SD Biosensor, Inc.–C-4&5 Floor, 16, Deogyeong-daero

TEST 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
Republic of Korea

41 COVID-19 IgG/IgM RAPID TEST CASSETTE Hangzhou Clongene Biotech Co Ltd. – No 1 Yichuang Road
Yuhang Sub district Yuhang District, Hangzhou, 311121 China

42 COVID-19 IgG/IgM Antibody Combo Rapid Test Shenzhen Huisong Technology Development Co., Ltd-
(Colloidal Gold) 2F/3F/5F, building 114, Liantang Industrial Park, Guowei
Road, Luohu District, Shenzhen, China

43 2019-nCoV IgG/IgM Rapid Test Dynamiker Biotechnology (Tianjin) Co., Ltd.-No. 14 Building,
Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore
Tianjin Eco-City, 300467 Tianjin, China

44 STANDARD Q COVID-19 IgM/IgG COMBO SD Biosensor, Inc.–C-4&5 Floor, 16, Deogyeong-daero

TEST 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
Republic of Korea

45 Diagnostic Kit for Antibody IgM-IgG of Novel Shanghai Liangrun Biomedicine Technology Co. Ltd- Level 4,
Coronavirus COVID-19 Building 1, No. 271, Gang’ao Road, Pilot Free Trade Zone,
Shanghai, China

46 Rapid Immunochromatographic Test for Detection Xiamen Biotime Biotechnology Co. – No.188, Pingcheng
of IgG/IgM Antibodies to Coronavirus 2019- South Road, Haicang District, Xiamen Fujian 361026, China /
nCoV / Standard Q Covid-19 (IgM / IgG) duo No. 188, Pingcheng, South Road, Haikang 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

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

48 CLUNGENE COVID-19 IgG/IgM RAPID TEST Hangzhou Clongene Biotech Co Ltd. – No 1 Yichuang Road
CASSETTE Yuhang Sub district Yuhang District, Hangzhou, 311121 China

49 SGTi-flex COVID-19 IgM/IgG Sugentech Inc. – 721-26 Jeongjungyeonje-ro Osong-eup,

Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28161,
Republic of Korea

50 NTBIO One Step Rapid Test COVID-19 IgG/IgM NTBIO Diagnostics Inc- 104-18677 52 Avenue, Surrey BC,
Antibody Test V3S 8E5 Canada

51 COVID-19 IgG/IgM Rapid Test Cassette (Whole Healgen Scientific Limited Liability Company – 3818 Fuqua
Blood/ Serum/ Plasma) Street Houston, TX 77047, USA

52 Novel Coronavirus (2019nCoV) IgG/IgM Test Kit Genrui Biotech Inc¬¬-4-10F, Building 3, Geya Technology
(Colloidal Gold) Park Guangming District, 518106 Shenzhen China

53 2019-nCoV IgG/IgM Rapid Test (DNK-1419-1) Dynamiker Biotechnology (Tianjin) Co. Ltd -No.14 Building,
Eco-Business Park 2018 Zhongtian Avenue Sino-Singapore
Tianjin Eco-City 300467 Tianjin China

54 SARS-COV-2 IgM Assay Kits (Lateral Flow 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

55 SARS-COV-2 IgG Assay Kits (Lateral Flow 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

56 Severe Acute Respiratory Syndrome Coronavirus Maccura Biotechnology Co., Ltd. – 16#, Baichuan Road, High-
2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Tech Zone, 611731 Chengdu, People’s Republic of China
Colloidal Gold Method

57 SARS-CoV-2 IgG/IgM Kit Goldsite Diagnostics Inc – #3A&4 A, Technology Building

Annex, Zhaoshang Sub-district, Nanshan District,
Shenzhen,518067 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

58 SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Joinstar Biomedical Technology Co., Ltd – 10th Floor,
Gold) (NL-CA002-2020-50068) Administration Building, NO.519, XingGuo RD., Yuhang
Economic and Technological Development Zone, Hangzhou,
Zhejiang, China

59 ACON SARS-CoV-2 IgG/IgM Rapid Test ACON Biotech (Hangzhou) Co., Ltd.– No.210 Zhenzhong
Road, West Lake District, Hangzhou, P.R. China

60 EURORealTime SARS-CoV-2 EUROIMMUN Medizinische Labordiagnostika AG. –

Seekamp 31 23560 Lubeck, Germany

61 Genrui Novel Coronavirus (2019-nCoV) IgG/IgM Genrui Biotech Inc¬¬-4-10F, Building 3, Geya Technology
Test Kit (Colloidal Gold) Park Guangming District, 518106 Shenzhen China

62 Novel Coronavirus (2019-nCoV) Antibody Test Shanghai Outdo Biotech Co., Ltd – 3F Building 2, 3F Building
Kit (Colloidal Gold) 4, 3F Building 5, No. 151 Libing Rd., Pilot Free Trade Zone,
201203 Shanghai, People’s Republic of China

63 V-CODE SAR-CoV-2 IgG/IgM Rapid Test Zhuhai Encode Medical Engineering Co., Ltd – No. 20,
Honghui 2nd Road, Hongqi Industrial Zone, Jinwan District,
Zhuhai, China

64 V-CODE SARS-CoV-2 IgG/IgM Rapid Test ACON Biotech (Hangzhou) Co., Ltd.– No.210 Zhenzhong
Road, West Lake District, Hangzhou, P.R. China

65 ENCODE SARS-CoV-2 IgG/IgM Rapid Test Zhuhai Encode Medical Engineering Co., Ltd – No. 20,
Honghui 2nd Road, Hongqi Industrial Zone, Jinwan District,
Zhuhai, China

66 COVID-19 IgG/IgM Rapid Test Kit Nantong Egens Biotechnology Co Ltd - Building 15 Building
12 (West), No 1692 Xinghu Avenue, Nantong Economy &,
Technology Development, Zone, Nantong, 226010 China

67 i-Test COVID -19 IgM/IgG Antibody Rapid Test Beijing Hotgen Biotech Co., Ltd – 9th Building, No 9 Tianfu
(Colloidal Gold) Street, Biomedical Base, Daxing District 102600 Beijing, 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

68 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit Biohit Healthcare (Hefei) Co., Ltd. – Building D9, Innovation
Park, No.800 West Wangjiang Road, High-Tech Zones, Hefei,
Anhui Province, P.R. China

69 COVID-19 (SARS-Cov-2) IgM/IgG Antibody Wuhan Easydiagnosis Biomedicine Co., Ltd. – Floor 1,
Test Kit Building 25, Phase 3.1, Wuhan Optics Valley International
Biomedical Enterprise Accelator, 388 High and New
Technology 2nd Road, East Lake New Technology
Development Zone, Wuhan, China

70 GenSureTM COVID-19 lgG / lgM Rapid Test Hebei Gensure Biotech Inc. – Bl-78, Rizhongtian Science and
Technology Park, N0. 585 Tianshan Street, Shijiazhuang High-
Tech Zone, Hebei, P.R. China.

71 SMART COVID-19 IgM-IgG RAPID CELL ID PTE LTD – 3 Gambas Crescent, Nordcom One, #09-
DIAGNOSTIC TEST 08, Singapore

72 MP Diagnostics ASSURE® SARS-CoV-2 MP Biomedicals Asia Pacific Pte Ltd – 2 Pioneer Place,
IgG/IgM Rapid Test Singapore

73 SARS-CoV-2 IgG/IgM Test Cassette (Colloidal HangZhou Testsea Biotechnology Co., Ltd– Building 6 No.8-2
Gold) Scien-tech Road, Yuhang Street Hangzhou -311121, China

74 ChekR™ COVID-19 IgM/IgG Rapid Test Kit B-bio, Co., Ltd. – B-bio Co., Ltd – #824, #B114, 25-32, LS-ro
116beon-gil, Dongan-gu Anyang-si, Gyeonggi-do 14118,
Republic of Korea

75 2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Biobase Biodustry (Shandong) Co., Ltd. – Biobase Biodustry
Gold) Park, Corssing of east Jingshi and Mingbu Road, Mingshui
Economic Development Zone, Zhangqiu, Jinan City, Shandong
Province, China

76 Novel Coronavirus(2019-nCoV) Antibody Shenzhen Landwind Biotechnology Co., Ltd – 6F, Block 10,
(IgG/IgM) Combined Test Kit Tong Fuyu Industrial Park, Taoyuan Street, Nanshan District,
(Immunochromatographic method) Shenzhen, 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

77 Humasis COVID-19 IgG/IgM Antibody Test Humasis Co., Ltd. – Rm.114, 502, 504, 604, 604-1, B03-1,
B03-2, 88, Jeonpa-ro, Dongan-gu, Anyang-si, Gyeonggi-do
14042, Republic of Korea

78 SARS-CoV-2 (Coronavirus Disease 2019) PharmACT AG - Rudower Chaussee 29, 12489 Berlin,
IgM/IgG Antibody Detection Reagent Kit Germany

79 BIOTIME SARS-CoV-2 IgG/IgM Rapid Xiamen Biotime Biotechnology Co. – 3F/4F, No.188,
Qualitative Test Pingcheng S. Road, Haicang District, Xiamen, Fujian 361026,
P. R. China

80 Assure COVID-19 IgG/IgM Rapid Test Device Assure Tech. (Hangzhou) Co., Ltd. – 2nd-5th Floor, Building 4,
No. 1418-50, Moganshan Road, Gongshu District, Hangzhou,
Zhejiang 310011, China

81 Zekmed Covid 19 IgG/IgM Rapid Tests Cassette- Zenum Sarl – Route Du Roule 3, 1723 Marly Switzerland
Zekcov19_3

82 SimtomaX CoronaCheck Rapid test for IgM / IgG Getein Biotech, Inc. – No. 9 Bofu Road, Luhe District, 211505,
antibodies to coronavirus (2019-nCoV) (colloidal Nanjing, Chin
gold)

83 careUS COVID-19 IgG / IgM WELLS Bio, Inc. – 16, Magokjungang 8-ro 1-gil, Gangseo-gu
Seoul 07795, Republic of Korea

84 CareStart COVID-19 IgM/IgG Access Bio, Inc. – 65 Clyde Road, Suite A, Somerset, NJ, USA

85 Corona Virus Disease-19 (COVID-19) IgG/IgM TBG Biotechnology Xiamen Inc. – No. 3 Building 4/F-1, No.
Rapid Cassette (S/P/WB) 2004 Wengjiao West Road, Haicang District, Xiamen City,
Fujiam Province, 361027 China

86 GenSureTM COVID-19 IgG/IgM Rapid Test Hebei GenSure Biotech Inc. – B1-78, Rizhongtian Science and
Technology Park, No.585 Tianshan Street, Shijiazhuang High-
tech Zone, 050000，Hebei, 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

87 GenSureTM COVID-19 IgG/IgM Rapid Test Hebei GenSure Biotech Inc. – B1-78, Rizhongtian Science and
Technology Park, No.585 Tianshan
Street, Shijiazhuang High-tech Zone, 050000，Hebei, P.R.
China

88 SARS-CoV-2 IgM Reagent kit Abbott Ireland Diagnostics Division – Finisklin Business Park,
Sligo, Ireland

89 cPassTM SARS-CoV-2 Neutralization Antibody Accelerate Technologies Pte Ltd (DxD Hub) – 10 Biopolis
Detection Kit Road #03-01/02 Chromos Building, Singapore

90 PARTNERS COVID-19 IgG/IgM RAPID TEST Hangzhou Biotest Biotech Co., Ltd. – 17# Futai Road Zhongtai
CASSETTE Street, Yuhang District, Hangzhou, People’s Republic of China

91 ABBOTT Alinity i SARS-CoV-2 IgM Abbott Ireland Diagnostics Division – Finisklin Business Park,
Sligo, Ireland

92 Aria COVID-19 IgG/IgM Rapid Test MANUFACTURER: CTK Biotech, Inc. – 13855 Stowe Dr.
Poway California, USA

93 qSARS-CoV-2 IgG/IgM Rapid Tests Dermaqual LLC. – 76/78 Ave. des Champs- Élysées, 75008,
Paris, France

94 SARS-CoV-2 Rapid Antibody Test SD Biosensor, Inc.–C-4&5 Floor, 16, Deogyeong-daero

1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
Republic of Korea

95 FREND COVID-19 total Ab NanoEntek, Inc. – 851-14 Seohae-ro, Paltan-myeon,

Hwaseong-si, Gyeonggi-do, Korea

96 SARS-CoV-2 IgG Screen IMBIAN LAB LLC. – Kolcovo, Vectornoe highway, 19/1
Novosibirsk, Russia

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

97 (2019-nCoV) New coronavirus Antibody Test Nantong Diagnos Biotechnology Co Ltd – 2nd Floor, building
(Colloidal Gold) 6 Electronic Information Industrial Park, No. 2 Haiyang South
Road, Chengnan Street, 226500 Rugao City, Jiangsu Province,
People’s Republic of China

98 COVID-19 IgG/IgM Rapid Test Biomerica, Inc. – 17571 Von Karman Ave. MDSS GmbH,
Schiffgraben 41, Irvine, CA 92614 USA

99 TBG SARS-CoV-2 IgG / IgM Rapid Test Kit TBG Biotechnology Corp. – 13F-1, No. 237, Sec. 1, Datong
Rd., Xizhi District, New Taipei City 221, Taiwan

100 MDGen-AB96 COVID-19 IgG MicroDigital Co., Ltd. – 7th Floor, 15, Pangyo-ro, 228 Beongil,
Bundang-Gu, Seongnam-Si, Gyeonggi-do, South Kore

101 Abbott Panbio™ COVID-19 lgG/lgM RAPID Abon Biopharm (Hangzhou) Co., Ltd. – #198, 12th Street
TEST DEVICE East Hangzhou Economic & Technological Development
Area 310018 Hangzhou People's Republic of China

102 A Rapid IgM-IgG Combined Antibody Test Jiangsu Medomics medical technology Co., Ltd – F3,
Kit for SARS-CoV-2 (ICA) BuildingD, No.3-1 XinjinhuRoad, Jiangbei New Area,
Nanjing, Jiangsu, China

103 DIMENSION EXL SARS-CoV-2 IgG Siemens Healthcare Diagnostics Inc. – 500 GBC Drive
(CV2G) Assay kit Newark, DE 19714, USA

104 Finecare™ SARS-CoV-2 IgM/IgG Test Guangzhou Wondfo Biotech Co., Ltd. – No.8 Lizhishan
Road, Science City, Luogang District, 510663,
Guangzhou, P.R. China

105 SARS-CoV-2 IgG II Quant Reagent Kit Abbott Ireland Diagnostics Division – Finisklin Business
Park, Sligo, Ireland

106 cPass SARS-CoV-2 Neutralization Antibody Genscript Biotech (Singapore) Pte Ltd – 1 Fusionopolis
Detection Kit Place, #03-20 Galaxis, 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

107 MAGLUMI® SARS-CoV-2 Neutralizing Shenzhen New Industries Biomedical Engineering Co.,
Antibody (CLIA) Ltd.– No.23, Jinxiu East Road, Pingshan District, 518122
Shenzhen, P.R. China

108 CHORUS SARS-COV-2 IgM Code: 81401 DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10,
53035 Monteriggioni (Siena) Italy

109 CHORUS SARS-COV-2 IgG Code: 81400 DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10,
53035 Monteriggioni (Siena) Italy

110 CHORUS SARS-COV-2 IgG Code: 81400 DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10,
53035 Monteriggioni (Siena) Italy

111 CHORUS SARS-CoV-2 Screen Serum Code: DIESSE Diagnostica Senese S.p.A.-Via delle Rose, 10,
81406 53035 Monteriggioni (Siena) Italy

112 MACCURA Severe Acute Respiratory Maccura Biotechnology Co., Ltd. – 16 # Baichuan Road,
Syndrome Coronavirus 2 (SARS-CoV-2) Hi-Tech Zone, 611731 Chengdu, People’s Republic of
IgM/IgG Antibody Assay Kit by Colloidal China
Gold Method

113 Anti-SARS-CoV-2 S Protein Antibody Test Xiamen Boson Biotech Co., Ltd. – 90-94 Tianfeng Road,
Card Jimei North Industrial Park, Xiamen, Fujian, 361021, P.R.
China

114 SARS-CoV-2 lgG /Neutralizing antibody JOYSBIO(Tianjin) Biotechnology Co., Ltd.– Tianjin
Rapid Test Kit (Colloidal Gold) International Joint Academy of Biotechnology& Medicine
9th floor No.220, Dongting Road, TEDA 300457 Tianjin
China

115 Dynamiker SARS-CoV-2 Neutralization Dynamiker Biotechnology (Tianjin) Co., Ltd. – No. 14
Antibody Rapid Test Building, Eco-Business Park, 2018 Zhongtian Avenue,
Sino-Singapore Tianjin Eco-City, 300467 Tianjin, 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