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 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 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) ...

SAN DIEGO, Jan. 23, 2026 /PRNewswire/ -- ACON Laboratories, Inc. today announced the retail availability of the first FDA-cleared home test which allows families to identify four major respiratory ...

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 ...

The warning is for the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” from ACON Laboratories. The test comes in a dark blue box with white lettering and symbols in the lower right corner of ...

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 ...