Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

List of Approved COVID-19 Test Kits for Commercial Use

as of 19 MAY 2020, 5:00PM

NO. PRODUCT NAME MANUFACTURER

1 Nucleic acid detection kit for 2019 ncov Shanghai GenoeDx Biotech Co., LTD- Shanghai , China.

2 Novel coronavirus 2019-ncov nucleic acid Beijing Applied Biological Technologies Co., Ltd-
detection kit (fluorescence PCR Changping District 102206 Beijing P.R
method)

3 AllplexTM 2019-nCoV Assay Seegene Inc. -Seoul, Republic of Korea

4 SOLGENT DiaPlexQ™ Novel Coronavirus Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu,
(2019-nCoV) Detection Kit Daejeon, South Korea

5 Standard M nCoV Real-time Detection Kit SD Biosensor, Inc.–C-4&5 Floor, 16, Deogyeong-daero
1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do,
16690, Republic of Korea

6 A*STAR FORTITUDE KIT 2.0 (COVID-19 Accelerate Technologies Pte. Ltd- Chromos Building,
Real-Time RT-PCR TEST) Singapore

7 TIB MOLBIOL LIGHTMIX® MODULAR

WUHAN CoV RdRP-GENE
TIB MOLBIOL Syntheselabor GmbH- Eresburgstraße 22
8 TIB MOLBIOL LIGHTMIX® MODULAR – 23 12103 Berlin Germany
SARS AND WUHAN COV E-GENE

9 GENESIG® REAL-TIME PCR Primerdesign Ltd. – Unit 1, Watchmoor Point,

CORONAVIRUS (COVID-19) CE IVD KIT Watchmoor Road, Camberley, GU15 3AD, United
Kingdom

10 BDDS - CerTest - SARS-CoV2 BD MAX Certest Biotech, S.L -Zaragoza (spain)Certest Biotech,
assay (SEVERE ACUTE RESPIRATORY S.L. – Calle J N°1 POL. IND. RIO GALLEGO II-50840
SYNDROME-ASSOCIATED San Mateo De Gallego (Zaragoza), Spain
CORONAVIRUS IVDs [CT772])

11 BioFire COVID-19 TEST Biofire Defense, LLC. – 79 West 4500 South, Suite
14 Salt Lake City, Utah 84107, USA

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: [email protected]
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

12 2019-nCov NUCLEIC ACID-BASED Sansure Biotech Inc. – No. 680, Lusong Road, Hi-
DIAGNOSTIC REAGENT KIT Tech Development Zone, Yuelu District, Changsha,
(FLOURESCENT PCR) Hunan Provice, 410205, People’s Republic of China

13 Xpert® Xpress SARS-CoV-2 Cepheid – 904 Caribbean Drive, Sunnyvale, CA 94089-

1189 USA

14 NUCLEIC ACID REAGENT TEST KITS Shanghai ZJ Bio-Tech Co., Ltd- – Floor 1, Building B,
FOR NOVEL CORONAVIRUS 2019-NCOV building 20, Floor 1, Building A, building 21, No. 528,
(FLUOROMETRIC PCR) Ruiqing Road, Zhangjiang high-tech Industry east district,
Shanghai, China

15 abTES™ COVID‐19 REAL‐TIME qPCR I AITbiotech Pte Ltd - 25 Pandan Crescent #05-15 TIC
KIT Tech Centre, Singapore

16 SARS-CoV-2 Fluorescent PCR Maccura Biotechnology Co., Ltd. – 16#, Baichuan Road,
High-Tech Zone, 611731 Chengdu, People’s Republic of
China

17 BGI Biotechnology (Wuhan) Co., Ltd. – Research and

REAL-TIME FLUORESCENT RT-PCR KIT Development Building B2, Wuhan National Bio-Industry
FOR DETECTING 2019-nCoV Base B, C, D Suite, No. 666, High-Technology Road,
Wuhan Donghu High-Technology Development Zone,
People’s Republic of China

18 TaqPath COVID-19 COMBO KIT Thermo Fisher Scientific, Inc. – 5781 Ban Allen Way,
Carlsbad, CA 92008, USA

19 ProTectTM COVID-19 RT-qPCR Kit (10024) JN Medsys Pte Ltd., -217 Henderson Road #02-08,
(10027) Singapore

20 cobas® SARS-CoV-2 MAT CODE: Roche Molecular Systems, Inc.- 4300 Hacienda Drive
09175431190 TO INCLUDE: cobas® SARS- Pleasanton, CA, USA
CoV-2 Control Kit P/N: 09175440190 AND
cobas® 6800/8800 Buffer Negative Control
Kit P/N: 07002238190

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: [email protected]
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

21 GENAMPLIFY™ CORONA VIRUS

DISEASE- 2019 (COVID - 19) rRT-PCR MANILA HEALTHTEK INC- 109 Brgy. Sta. Elena,
DETECTION KIT Mayor Gil Fernando Avenue, Marikina City

22 LOGIX SMART CORONAVIRUS DISEASE Co-Diagnostics, Inc. – 2401 S Foothill Dr. Suite D, Salt
2019 (COVID-19) KIT Lake City, UT 84109, USA

23 Abbott RealTime SARS-CoV-2 ASSAY Abbott Molecular, Inc– 1300 E. Touhy Avenue, Des
Plaines, IL 60018 USA

24 PowerChekTM 2019-nCoV Real-time PCR KogeneBiotech Co., Ltd- RM1101, C-dong, 168,
Kit Gasandigital 1-ro, Geumcheon-gu, Seoul, South Korea

25 BD SARS-CoV-2 REAGENTS for BD MAX Becton, Dickinson and Company -7 Loveton Circle
System Sparks, MD 21152, USA

26 Novel Coronavirus 2019-nCoV Nucleic Acid Sun Yat-Sen University Da An Gene Company Limited
Reagent Kit (Fluorescence PCR Detection) manufactured by: Guangzhou Hi-Tech Industry
Development Zone, No. 19, Xiang Shan Rd., Guangzhou,
China

27 NOVEL CORONAVIRUS (2019-NCOV) Shanghai Fosun Long March Medical Science Co., Ltd. –
NUCLEIC ACID DETECTION KIT 830 Chengyin Road, Baoshan District, People's Republic
(FLUORESCENCE PCR) of China

28 Smart Detect SARS-CoV-2 rRT-PCR Kit InBios International Inc. – 307 Westlake Ave North Suite
300, Seattle, WA 98109, United States

29 GeneFinder™ COVID-19 Plus Real Amp Kit OSANG Healthcare Co., Ltd – 132, Anyangcheondong-
ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040 Korea

30 Real-Time Fluorescent RT-PCR Kit for BGI Genomics Co. Ltd.-BGI Genomics Co. Ltd. – 250
Detecting SARS-2019 nCoV West 55th Street, New York, NY 10019 USA

31 PERKINELMER NEW CORONAVIRUS Suzhou Sym-Bio Lifescience Co. Ltd. - No. 115, North
NUCLEIC ACID DETECTION KIT Tai Ping Road, Taicang Economic Development Zone,
215400 Jiangsu Province, 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: [email protected]
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

32 2019-nCoV NUCLEIC ACID TESTING KIT Wuhan Easydiagnosis Biomedicine Co., Ltd. – Room3,
(FLUORESCENCE PCR METHOD) Factory (3),1ST Floor, BLDG 25 Phase3.1 Wuhan Optics
Valley International Biopharmaceutical Enterprise
Accelerator, NO.388, Gaoxin 2nd Road East Lake HI-
Tech Development Zone, Wuhan, Hubei, China

33 MiRXES Fortitude Kit 2.0E (4480001) MiRXES Pte Ltd - 2 Tukang Innovation Grove JTC
MedTech Hub #08-01, Singapore

34 FOSUN COVID-19 RT-PCR DETECTION Fosun Pharma USA Inc.- 104 Carnegie Center, Suite 204-
KIT Princeton, NJ 08540, USA

35 REAL-Q 2019-nCoV DETECTION KIT Biosewoom Inc- 1F #102, 2F #204,205,206, 144,

Achasan-ro, Seongdong-gu, Seoul, 04783, Rep, of Korea

36 Primerdesign Ltd COVID-19 genesig Real- Primerdesign Ltd. – Unit 1, Watchmoor Point,
Time PCR assay Watchmoor Road, Camberley, GU15 3AD, United
Kingdom

37 QuantiVirus SARS-CoV-2 Test kit Diacarta, Inc. – 2600 Hilltop Drive, Richmond, CA
94806, USA

38 LabGun COVID-19 RT-PCR Kit Labgenomics Co., Ltd- #1204, 12F, 147, Gwanggyo-ro,
Yeongtong-gu, Suwon-si, Gyeonggi-do 16229, Republic
of Korea

39 FTD SARS-CoV-2 Fast Track Diagnostics Luxembourg S.à.r.l. – 29, rue

Henri Koch, L-4354 Esch-sur-Alzette, Luxembourg

40 Fosun COVID-19 RT-PCR Detection Kit Shanghai Fosun Long March Medical Science Co., Ltd. –
830 Chengyin Road, Baoshan District, People's Republic
of China

41 Novel Coronavirus (2019-nCoV) Nucleic Sansure Biotech Inc. – No.680, Lusong Road, Hi-Tech
Acid Diagnostic Kit (PCR-Fluorescence Development Zone, Yuelu District, Changsha, Hunan
Probing) Province, 410205, People’s Republic of 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: [email protected]