(Washington, D.C.) – The U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18.
The Flowflex COVID-19 Antigen Home Test is a visually-read test cleared for OTC home use by symptomatic individuals within six days of symptom onset. It is cleared for individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older.
