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