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FDA grants emergency use for at-home COVID-flu test - CIDRAP This is for informational purposes only
In February 2023, the FDA granted Emergency Use Authorization to Lucira Health for the first over-the-counter at-home test for COVID-19 and influenza, a 30-minute molecular test. Despite this breakthrough, the manufacturer filed for Chapter 11 bankruptcy just prior to the authorization, citing a protracted regulatory process, and was later acquired by Pfizer. For details on current authorized options, visit the FDA’s List of Authorized At-Home Tests . citing a protracted regulatory process