Business · 13/01/2022
FDA Revokes Emergency Use Authorizations for COVID-19 Diagnostic Devices
The FDA has revoked three Emergency Use Authorizations for COVID-19 diagnostic devices, including the BioGX SARS-CoV-2 Reagents for BD MAX System, BMC-CReM COVID-19 Test, and Akron Children's Hospital SARS-CoV-2 Assay, due to reasons outlined in the revocation document.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →