Business · 09/05/2022

FDA Revokes COVID-19 Diagnostic Device Authorizations

The Food and Drug Administration (FDA) has revoked two Emergency Use Authorizations (EUAs) for COVID-19 diagnostic devices, issued to Bio-Rad Laboratories, Inc. and Applied DNA Sciences, Inc. The revocations are due to the expiration of the EUAs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).