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FDA Revokes EUA for Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test

americanpharmaceuticalreviewAugust 13, 2020

Tag: FDA , Autobio Diagnostics , SARS-CoV-2

The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of the Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Tests for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2 due to performance concerns with the accuracy of the test. This test may not be distributed.

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