A test that can help to diagnose the flu as well as COVID-19 is headed to US drugstore shelves. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test, which received Food and Drug Administration clearance on 8 October, is the first OTC test for both diseases to be cleared via a traditional review pathway.
De Novo Clearance For HealGen Flu/COVID-19 Test
FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway.
