List of Approved COVID-19 Test Kits for Commercial Use
The FDA Philippines issued Advisory No. 409-20 on March 19, 2020, providing a list of approved COVID-19 test kits for commercial use. These kits, which are PCR-based and designed for laboratory use, have met the regulatory requirements outlined in FDA Memorandum No. 2020-006. The advisory includes specific products from various manufacturers, such as Shanghai GenoeDx and Seegene, and emphasizes that the list will be regularly updated. The public is encouraged to report any unapproved sales or distribution of COVID-19 test kits through the FDA's online reporting system.
Law Information
- Reference Number
- FDA Advisory No. 409-20
- Date Enacted
- Subcategory
- Food and Drugs Administration of the Philippines
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
March 19, 2020
FDA ADVISORY NO. 409-20
| TO | : | The General Public |
| SUBJECT | : | 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. aScITE
|
PRODUCT NAME |
MANUFACTURER |
DISTRIBUTOR |
|
Nucleic acid detection kit for 2019 ncov |
Shanghai GenoeDx Biotech Co., Ltd.-Shanghai, China |
S & S Enterprise |
|
Novel coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR method) |
Beijing Applied Biological Technologies Co., Ltd.-Changping District 102206 Beijing P.R. |
Sahar International |
|
AllplexTM 2019-nCoV Assay |
Seegene, Inc.-Seoul, Republic of Korea |
Endure Medical, Inc. |
|
SOLGENT DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit |
Solgent Co., Ltd.-3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea |
Wellness Pro, Incorporated |
This list shall be regularly updated. For reference please click the link. https://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez.
To report any sale or distribution of COVID-19 test kits not included in the list, you may utilize our online reporting facility, eReport at www.fda.gov.ph/report, or email us via [email protected].
(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General
Cite This Law
List of Approved COVID-19 Test Kits for Commercial Use, FDA Advisory No. 409-20, Mar 19, 2020 (Philippines)
List of Approved COVID-19 Test Kits for Commercial Use, FDA Advisory No. 409-20 (Phil. 2020)
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