Flowflex SARS-CoV-2 Antigen Rapid Test has been authorised for as a self-test by the Australian Government Department of Heath Therapeutic Goods Administration (TGA). The TGA’s performance requirements for COVID-19 rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO), and the European Commission. This includes a clinical sensitivity of […]
Tag: Flowflex
Flowflex™ COVID-19 Home Test Receives FDA EUA
ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex™ COVID-19 Antigen Home Test has been authorised for emergency use (EUA) by the U.S. Food and Drug Administration. The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a […]
Flowflex and Healgen Lateral Flow Rapid Antigen Tests – FAQs
What is a Lateral Flow Rapid Antigen Test? A SARS-COV-2 lateral flow antigen rapid test is used to quickly process samples on-site without the need for laboratory equipment, generating results in minutes. This kind of rapid diagnostic test is suitable for point-of-care and self-testing (dependant on brand), that directly detects the presence or absence of […]
ACON’s Flowflex test receives CE mark for self-testing
ACON, one of the professional in-vitro diagnostic products manufacturers, has announced that its Flowflex SARS-CoV-2 Antigen Rapid Test has been CE marked for self-testing throughout the European Union. The CE certificate is issued by TUV SUD (CE0123) and validated from 14th May 2021 until 26th May 2024. SARS-CoV-2 Antigen tests play a critical role in the fight […]