FDA Releases List of Approved Covid-19 Kits

The Department The Food and Drug Administration (FDA) released on Thursday a list of approved coronavirus disease 2019 (Covid-19) test kits for commercial use.

In a statement, the FDA said the kits are PCR-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits.

“FDA has released an initial list of approved kits with Special Certification. There are still pending applications that are due for evaluation. The list shall be regularly updated,” FDA Director General Eric Domingo said.

Domingo said the manufacturers of the kits have complied with the requirements as stated in the FDA Memorandum No. 2020-006 or the “Issuance of Special Certification for Imported Test Kits of Covid-19”.

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“FDA is hard at work in processing Covid-19 related applications during this time. We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized,” he added.

Domingo also urged the public to be vigilant about the entry of counterfeit products and “be watchful of those who try to take advantage of the current situation”. (PNA)