News
ACON Laboratories Issues a Recall of non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market
SAN DIEGO, CA, January 9, 2022 – ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and...
UPDATED STATEMENT ON THE OMICRON VARIANT
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants, including the Omicron variant. We are pleased to report that an independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that...
STATEMENT ON THE OMICRON VARIANT
We at ACON Laboratories, Inc. have been continuously monitoring the emergence of SARS-CoV-2 variants and the Omicron variant is no exception. The Omicron variant is notable for the significant number of mutations in the Spike protein. Those mutations are not relevant...
Flowflex™ COVID-19 Home Test Receives FDA EUA
SAN DIEGO, CA., October 4, 2021 – ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex™ COVID-19 Antigen Home Test has been authorized for emergency use by the U.S. Food and Drug Administration.The...
ACON Laboratories, Inc. receives Emergency Use Authorization (EUA) for its SARS-COV-2 IgG/IgM Rapid Test
COVID-19 Rapid Test San Diego, CA, December 17, 2020 -- ACON Laboratories, Inc., a leading global medical device manufacturer announced today that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency use by FDA under an EUA for use by authorized...
ACON received FDA clearance for its Distinct® Early Detection Pregnancy Test
Distinct Early Detection Pregnancy Test San Diego, CA -- ACON Laboratories, Inc., a leading global of rapid tests, point of care diagnostics and medical devices is pleased to announce that it received FDA Over The Counter (OTC) clearance for its Distinct® Early...
Website Launch – oncallmeters.com
ACON Laboratories, a leading maker of high quality and affordable diagnostic and medical devices, is excited to announce the launch of its newly designed website at oncallmeters.com.
ACON announces the launch of its Flowflex™ Antigen COVID-19 test
San Diego, CA, November 2, 2020 -- ACON Laboratories, Inc., a leading global medical device manufacturer announced today the launch of its Flowflex™ SARS-COV-2 Antigen Rapid Test. The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic...
ACON Labs Included in a Retrospective Clinical Evaluation of 4 Lateral Flow Assays for the Detection of SARS-CoV-2 IgG
San Diego, CA, September 17, 2020 ACON Laboratories, Inc. announced the results of an independent evaluation of its ACON SARS-CoV-2 IgG/IgM Rapid Test to be published in November. The article, including the results of the independent evaluation, is now available...
ACON Laboratories, Inc. Announces International Availability of SARS-CoV-2 Rapid Test
San Diego, CA, May 7, 2020 -- ACON Laboratories, Inc., a leading global medical device manufacturer, announced today the availability of its SARS-COV-2 IgG/IgM Rapid Test. ACON’s test is a lateral flow chromatographic immunoassay for the qualitative detection of...