SAN DIEGO, CA., January 22, 2026 — ACON Laboratories, Inc. today announced the retail availability of the first FDA-cleared home test which allows families to identify four major respiratory infections, including Respiratory Syncytial Virus (RSV), in adults and children as…
Since the launch of its Flowflex Plus COVID-19 and Flu A/B Home Test, ACON Laboratories, Inc. has continued testing for product stability to extend the shelf-life. These results have been shared with the FDA. We are pleased to announce that…
SAN DIEGO, CA., May 12, 2025 – ACON Laboratories, Inc., a leading global medical device manufacturer, announced today that its Flowflex® Plus COVID-19 + Flu A/B Home Test has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). The Flowflex Plus COVID-19…
ACON Laboratories, Inc. sophie rain hot has become aware of counterfeit Flowflex COVID-19 Antigen Home Test kits displaying Lot number COV3090017 which are being illegally sold in the United States and Puerto Rico by unauthorized distributors.Although these counterfeit test kits…
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 appear to…
ACON Laboratories, Inc. has become aware of counterfeit Flowflex COVID-19 Antigen Home Test kits displaying Lot number COV3060007 which are being illegally sold in the United States by unauthorized distributors. Although these counterfeit test kits appear to display an authentic…
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…
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. Among the new…
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)…
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…