Business · 13/03/2023
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 BinaxNOW COVID-19 Ag 2 Card and the Advanta Dx SARS-CoV-2 RT-PCR Assay and COVID-19 EASE Assay, issued to Abbott Diagnostics Scarborough, Inc. and Standard BioTools, Inc.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →