ACON Laboratories, Inc. has become aware of counterfeit Flowflex COVID-19 Antigen Home Test kits displaying Lot number COV3090005 which are being illegally sold in the United States and Puerto Rico by unauthorized distributors. Although these counterfeit test kits...
SAN DIEGO, CA., July 29, 2024 – ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex® Plus COVID-19 and Flu A/B Home Test has been authorized for emergency use by the U.S. Food and Drug Administration....
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. According to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the Omicron variant remains the dominant variant circulating in the United States....
SAN DIEGO, CA, November 9, 2023 – ACON Laboratories, Inc. is proud to announce that the U.S. Food & Drug Administration (FDA) has granted 510(k) marketing clearance for the Flowflex® COVID-19 Antigen Home Test. This is the first FDA 510(k) for an over-the-counter...
ACON Laboratories, Inc. is aware of the announcement by the Philadelphia Department of Public Health of a recall of certain at-home COVID-19 tests on September 9, 2023, and actively working with them and the FDA to conduct further investigation. The Lot number of...
