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…
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…
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 nearly all sequences…
ACON Laboratories, Inc., has become aware that counterfeit versions of its FDA-authorized Flowflex® COVID-19 Antigen Home Tests in the 1 Test/ kit box configuration marked as Lot# COV2010030 and COV2030016 are being illegally distributed in the United States through unauthorized…
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. The Omicron variant of concern remains the dominant variant circulating globally, accounting for nearly all sequences submitted to GISAID. Among the Omicron variant, BA.2.12.1, BA.4, and BA.5 represent…
We at ACON Laboratories, Inc. have been continuously monitoring the emergence of COVID-19 variants. The Omicron variant (B.1.1.529) is currently the dominant variant circulating globally, accounting fornearly all sequences reported to GISAID. Omicron is made up of several sub-lineages, the…
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 misbranded counterfeit product having…
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 the Flowflex™ COVID-19…
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…
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…