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Genovate offered an HIV dried blood spot (DBS) card self-collection kit for sale in the United States without obtaining required marketing authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to secure either a premarket approval (PMA) or investigational device exemption (IDE), making the device adulterated, and did not provide the required section 510(k) notification to FDA, rendering it misbranded. FDA had previously notified Genovate of these violations in a March 31, 2025 letter before issuing this formal warning.