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