A coronavirus antigen test has been recalled after officials discovered that it was a counterfeit and not approved by the Food and Drug Administration (FDA) for use in the United States. ACON ...

The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway. Acon Laboratories secured the 510(k) clearance for its ...

The Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) kit isn’t authorized for sale in the United States. FDA ACON Laboratories wants U.S. consumers to use its “Flowflex COVID-19 Antigen Home Test ...

ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced that its Flowflex Covid-19 Antigen Home Test has been authorized for emergency use by the US Food and Drug ...

SAN DIEGO — The U.S. Food and Drug Administration this week took action to increase peoples' access to rapid, at-home COVID-19 tests by issuing an emergency use authorization for a product made by a ...

The U.S. Food and Drug Administration (FDA) announced Monday that it had issued an emergency use authorization for the ACON Laboratories Flowflex COVID-19 Home Test. The over-the-counter (OTC) ...

ACON Laboratories wants U.S. consumers to use its “Flowflex COVID-19 Antigen Home Test,” not its “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)“ because the latter is a counterfeit test — in ...