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) ...

Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use ...

The US Food and Drug Administration has granted an Emergency Use Authorization to an over-the-counter (OTC) COVID-19 test that agency officials say will double at-home testing capacity. The ...

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 ...