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 ...

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 ...

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 ...

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 ...

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 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 ...

Don’t use these three COVID antigen tests, the FDA says. There’s a risk of a false negative or positive result when trying to detect the virus with them. Andrew Harnik AP There are three COVID-19 ...

“As one of the largest distributors of Acon Industries Flowflex COVID 19 Antigen Home Tests, we’re pleased to be an Authorized Distributor for Acon Laboratories,” commented Kevin Finley, CEO ...

WALTHAM, Mass., Feb. 24 /PRNewswire-FirstCall/ -- Inverness Medical Innovations, Inc. announced today that it has entered into a definitive agreement with ACON ...

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 ...