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Genetrace offered an HIV dried blood spot (DBS) card self-collection kit for sale in the United States without FDA marketing authorization, violating the Federal Food, Drug, and Cosmetic Act. The device was found to be adulterated because it lacked an approved Premarket Approval (PMA) application or Investigational Device Exemption (IDE), and misbranded because the company failed to provide the required notification of intent to introduce the device into commercial distribution under section 510(k). The FDA had previously notified Genetrace of these violations in a March 31, 2025 letter, indicating this was a continuation of ongoing non-compliance.