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Posted June 20, 2020

FDA Warns Companies Selling Unapproved COVID-19 Tests

On June 17, the FDA issued warning letters to three companies for marketing unapproved, adulterated or misbranded antibody tests for coronavirus (COVID-19). The agency also emphasized to consumers that there are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home.

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