FDA Advisory No. 2020-409 || List of Approved COVID-19 Test Kits for Commercial Use

As the Philippine Government continues to exhaust all efforts to respond to the current COVID-19 pandemic, the Food and Drug Administration (FDA) – Philippines hereby provides an initial list of approved COVID-19 Test Kits for commercial use. The kits in the list below have complied with the requirements as per FDA Memorandum No. 2020-006 entitled, “Issuance of Special Certification for Imported Test Kits of COVID-19.” These are PCR based kits used in laboratories, and not point-of-care kits.

PRODUCT NAME MANUFACTURER
Nucleic acid detection kit for 2019 ncov Shanghai GenoeDx Biotech Co., LTD- Shanghai, China.
Novel coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR

method)

Beijing Applied Biological Technologies Co., Ltd- Changping District 102206 Beijing P.R
AllplexTM 2019-nCoV Assay Seegene Inc. -Seoul, Republic of Korea
SOLGENT DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea

This list shall be regularly updated. For reference please click the linkhttps://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez.

To report any sale or distribution of COVID-19 test kits not included in the list, email us at [email protected].

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