FDA authorizes first over-the-counter test for both flu and COVID-19
The Food and Drug Administration Friday authorized for emergency use the first over-the-counter test to detect both flu and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test provides results from self-collected nasal swab samples in about 30 minutes.
Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health, called the authorization “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.”
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