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 ...

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 ...

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 (FDA) has cleared ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, the first over-the-counter (OTC) antigen test. Previously, the test was authorized for ...

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 ...

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 ...

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) ...

The U.S Food and Drug Administration on Monday authorized a new coronavirus home test that the agency says will soon double the nation's limited supply of non-prescription tests. The FDA's emergency ...