Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

摘要

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc. for the SCoV-2 Detect Neutralizing Ab ELISA, and Roche Diagnostics for the Elecsys Anti-SARS-CoV-2. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder.