Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
List of Approved COVID-19 Test Kits for Commercial Use as of 22 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 detection kit (fluorescence PCR method)
Beijing Applied Biological Technologies Co., LtdChangping District 102206 Beijing P.R
3
AllplexTM 2019-nCoV Assay
Seegene Inc. -Seoul, Republic of Korea
4
SOLGENT DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit
Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu, 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 Real-Time RT-PCR TEST)
Accelerate Technologies Pte. Ltd- Chromos Building, Singapore
7
TIB MOLBIOL LIGHTMIX® MODULAR WUHAN CoV RdRP-GENE TIB MOLBIOL Syntheselabor GmbH- Eresburgstraße 22 – 23 12103 Berlin Germany
8
TIB MOLBIOL LIGHTMIX® MODULAR SARS AND WUHAN COV E-GENE
9
GENESIG® REAL-TIME PCR CORONAVIRUS (COVID-19) CE IVD KIT
Primerdesign Ltd. – Unit 1, Watchmoor Point, Watchmoor Road, Camberley, GU15 3AD, United Kingdom
10
BDDS - CerTest - SARS-CoV2 BD MAX assay (SEVERE ACUTE RESPIRATORY SYNDROME-ASSOCIATED CORONAVIRUS IVDs [CT772])
Certest Biotech, S.L -Zaragoza (spain)Certest Biotech, S.L. – Calle J N°1 POL. IND. RIO GALLEGO II-50840 San Mateo De Gallego (Zaragoza), Spain
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 Website: www.fda.gov.ph
Fax +63 2 807 0751 Email: info@fda.gov.ph
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO.
PRODUCT NAME
MANUFACTURER
12
2019-nCov NUCLEIC ACID-BASED DIAGNOSTIC REAGENT KIT (FLOURESCENT PCR)
Sansure Biotech Inc. – No. 680, Lusong Road, HiTech Development Zone, Yuelu District, Changsha, Hunan Provice, 410205, People’s Republic of China
13
Xpert® Xpress SARS-CoV-2
Cepheid – 904 Caribbean Drive, Sunnyvale, CA 940891189 USA
14
NUCLEIC ACID REAGENT TEST KITS FOR NOVEL CORONAVIRUS 2019-NCOV (FLUOROMETRIC PCR)
Shanghai ZJ Bio-Tech Co., Ltd- – Floor 1, Building B, building 20, Floor 1, Building A, building 21, No. 528, Ruiqing Road, Zhangjiang high-tech Industry east district, Shanghai, China
15
abTES™ COVID‐19 REAL‐TIME qPCR I KIT
AITbiotech Pte Ltd - 25 Pandan Crescent #05-15 TIC 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 REAL-TIME FLUORESCENT RT-PCR KIT FOR DETECTING 2019-nCoV
BGI Biotechnology (Wuhan) Co., Ltd. – Research and Development Building B2, Wuhan National Bio-Industry Base B, C, D Suite, No. 666, High-Technology Road, Wuhan Donghu High-Technology Development Zone, People’s Republic of China Thermo Fisher Scientific, Inc. – 5781 Ban Allen Way, Carlsbad, CA 92008, USA
18
TaqPath COVID-19 COMBO KIT
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: 09175431190 TO INCLUDE: cobas® SARSCoV-2 Control Kit P/N: 09175440190 AND cobas® 6800/8800 Buffer Negative Control Kit P/N: 07002238190
Roche Molecular Systems, Inc.- 4300 Hacienda Drive Pleasanton, CA, USA
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Website: www.fda.gov.ph
Fax +63 2 807 0751 Email: info@fda.gov.ph
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO. 21
PRODUCT NAME
MANUFACTURER
GENAMPLIFY™ CORONA VIRUS DISEASE- 2019 (COVID - 19) rRT-PCR DETECTION KIT
MANILA HEALTHTEK INC- 109 Brgy. Sta. Elena, 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 Kit
KogeneBiotech Co., Ltd- RM1101, C-dong, 168, Gasandigital 1-ro, Geumcheon-gu, Seoul, South Korea
25
BD SARS-CoV-2 REAGENTS for BD MAX System
Becton, Dickinson and Company -7 Loveton Circle Sparks, MD 21152, USA
26
Novel Coronavirus 2019-nCoV Nucleic Acid Reagent Kit (Fluorescence PCR Detection)
Sun Yat-Sen University Da An Gene Company Limited manufactured by: Guangzhou Hi-Tech Industry Development Zone, No. 19, Xiang Shan Rd., Guangzhou, China
27
NOVEL CORONAVIRUS (2019-NCOV) NUCLEIC ACID DETECTION KIT (FLUORESCENCE PCR)
Shanghai Fosun Long March Medical Science Co., Ltd. – 830 Chengyin Road, Baoshan District, People's Republic 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, Anyangcheondongro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040 Korea
30
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019 nCoV
BGI Genomics Co. Ltd.-BGI Genomics Co. Ltd. – 250 West 55th Street, New York, NY 10019 USA
31
PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT
Suzhou Sym-Bio Lifescience Co. Ltd. - No. 115, North 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 Website: www.fda.gov.ph
Fax +63 2 807 0751 Email: info@fda.gov.ph
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO.
PRODUCT NAME
MANUFACTURER
32
2019-nCoV NUCLEIC ACID TESTING KIT (FLUORESCENCE PCR METHOD)
Wuhan Easydiagnosis Biomedicine Co., Ltd. – Room3, Factory (3),1ST Floor, BLDG 25 Phase3.1 Wuhan Optics Valley International Biopharmaceutical Enterprise Accelerator, NO.388, Gaoxin 2nd Road East Lake HITech 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 KIT
Fosun Pharma USA Inc.- 104 Carnegie Center, Suite 204Princeton, 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 RealTime PCR assay
Primerdesign Ltd. – Unit 1, Watchmoor Point, 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 Acid Diagnostic Kit (PCR-Fluorescence Probing)
Sansure Biotech Inc. – No.680, Lusong Road, Hi-Tech Development Zone, Yuelu District, Changsha, Hunan Province, 410205, People’s Republic of China
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Website: www.fda.gov.ph
Fax +63 2 807 0751 Email: info@fda.gov.ph
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
42
1copy COVID-19 qPCR Multi Kit
1DROP INC. – A-203, Keumkang Penterium IT Tower 215, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13217, Republic of Korea
43
DirectDetectTMSARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) (NL-CA002-202049934)
Coyote Bioscience Co., Ltd – Room 509/510, 5F Chuangye Zhong Road, #36 Haidan District, 100085, Beijing, China
44
iAMP-COVID 19 Detection Kit
Atila BioSystems Inc- 740 Sierra Vista Ave, Mountain View, CA 94043, United States
45
Lyra® Direct SARS-CoV-2 Assay
Quidel Corporation-2005 East State Street, Suite 100 Athens, OH 45701 USA
* Updated list in yellow highlights
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Website: www.fda.gov.ph
Fax +63 2 807 0751 Email: info@fda.gov.ph