FDA approves 8 Covid-19 test kits for commercial use

The Food and Drug Administration (FDA) has approved eight novel coronavirus disease 2019 (Covid-19) test kit products for commercial use.

Two of the approved kits are from Korea and two are from China.

The FDA has not yet approved any point-of-care or rapid test kits for COVID-19.

These approved kits are PCR-based reagent kits intended for use by hospitals or laboratories with testing capacity, not for point-of-care or home use.

The four products have complied with the FDA's requirements under Memorandum No. 2020-006.

The Department of Health (DOH) has sent equipment to sub-national labs in Davao, Cebu, and Baguio for testing.

The country's testing capacity is currently limited due to a shortage of test kits, though more are expected to arrive soon to boost capabilities.

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