FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: REVOCATION OF THREE AUTHORIZATIONS OF EMERGENCY USE OF IN VITRO DIAGNOSTIC DEVICES FOR DETECTION AND/OR DIAGNOSIS OF COVID-19; AVAILABILITY

WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability.

The notice was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 DetectNeutralizing Ab ELISA, and Roche Diagnostics for the Elecsys Anti-SARS-CoV-2. FD...