Flowflex News & Product Updates

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 the request to extend the Flowflex Plus COVID-19 and Flu A/B Home Test shelf-life from 15 months to 24 months, when stored at 36-86°F (2-30°C), has been granted. The Flowflex Plus COVID-19 and Flu A/B Home Test has an expiration date that is extended by 9 months. Look up the new expiration date using the lot number printed on the test kit box. Future shelf-life expiration date extensions will be communicated as they become available. If you have questions, please

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 + Flu A/B Home Test (K250377) is an over-the-counter (OTC) rapid antigen test that can be administered in the comfort and privacy of consumers’ homes. This version of the test will continue to be manufactured domestically in ACON’s state-of-the-art San Diego, CA facility. The Flowflex Plus COVID-19 and Flu A/B Home Test received Emergency Use Authorization (EUA) in July 2024, as a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.

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. The new Flowflex Plus COVID-19 and Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs