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, March 20 -- 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 March 20 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Beckman Coulter, Inc, for the Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations...