FDA issues EUA for first 2019 novel coronavirus diagnostic

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Under this EUA, the use of the 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to CDC-designated qualified laboratories and, in the U.S., those certified to perform high complexity tests. There are no commercially available diagnostic tests cleared or approved by the FDA for the detection of 2019-nCoV.