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FDA Issues Revised Reauthorization Of CDC COVID-19 Test, OK’s Change To New York Test

 
• By Sue Darcey

The US agency issued a revised version of an Emergency Use Authorization (EUA) to the Centers for Disease Control and Prevention for the CDC’s COVID-19 test on 15 March, and approved an amendment to New York State’s EUA for its assay on the same day.

test tube of covid-19 and virus

A revised version of the US Centers for Disease Control and Prevention’s coronavirus diagnostic was reauthorized by the Food and Drug Administration on 15 March, FDA commissioner Stephen Hahn announced in a 16 March series of tweets.

The CDC’s test, known as the CDC 2019-Novel Coronavirus Real-Time Reverse Transcriptase RT-PCR Diagnostic Panel, was initially authorized by the FDA on 4 February under its Emergency Use Authorization (EUA)...

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More from Policy & Regulation

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