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Flowflex® Plus COVID-19 and Flu A/B Home Test Receives FDA EUA
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....
Trade Shows 2024
ECRM Diabetes, Diagnostics& Clinical Session May 8-11, 2024 Westin Kansas City at Crown Center Kansas City, Missouri ADLM (formerly AACC) Association for Diagnostics & Laboratory Medicine July 28-August 1, 2024 McCormick Place Convention Center Chicago,...
STATEMENT ON THE OMICRON BA.2.86 and JN.1 VARIANTS
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....
ACON Receives FDA 510(k) Clearance for Flowflex® COVID-19 Test; Will be Manufactured in San Diego
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...
Recall Issued by the Philadelphia Department of Public Health for Counterfeit Flowflex COVID-19 Tests
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...
ACON Laboratories, Inc. Announces the Launch of On Call® MultiPro
HbA1c, ACR and CRP Now Available in Europe and Latin America San Diego — August 30, 2023, ACON Laboratories, Inc. announced availability of the On Call® MultiPro System for point-of-care testing in physician offices, clinics and hospitals. The system features...
STATEMENT ON THE OMICRON EG.5 and FL.1.5.1 VARIANT
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,...
Flowflex COVID-19 Antigen Home Test New Shelf-life Extension
Since the launch of its Flowflex COVID-19 Antigen 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...
STATEMENT ON THE NEW OMICRON VARIANTS (BQ.1.1, BQ.1, XBB.1.5, XBB, and BF.7)
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants to ensure that the Flowflex® COVID-19 Antigen Home Test can detect them. The Omicron variant of concern remains the dominant variant circulating globally, accounting for...
Trade Shows 2023
ECRM Diabetes, Diagnostic & Clinical Session May 8-11, 2023 Green Valley Ranch Resort & Spa Henderson, Nevada AACC American Association for Clinical Chemistry July 25-27, 2023 Anaheim Convention Center Anaheim, California Booth 1547 NACDS National Association...