FDA Revokes Emergency Use Authorization for Autobio Diagnostics SARS-CoV-2 Serology Test

Aug 07, 2020

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NEW YORK – The US Food and Drug Administration has revoked its Emergency Use Authorization for Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Tests for IgM and IgG antibodies due to concerns about its accuracy, the agency said on Friday.

The test can no longer be distributed in the US.

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FDA Revokes Emergency Use Authorization for Autobio Diagnostics SARS-CoV-2 Serology Test

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