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

WASHINGTON, May 29 -- Food and Drug Administration has issued a notice called: Revocation of Four 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 May 29 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 Pfizer Inc. for the Lucira COVID-19 All-In-One Test Kit and Lucira CHECK-IT COVID-19 Test Kit, MAWD Laboratories for the MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR, and Nuclein, LLC (merged with Molecular Diagnostics In...