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Germaphobix was warned for marketing an HIV dried blood spot self-collection kit without required FDA authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company's product was determined to be adulterated because it lacked an approved premarket approval (PMA) application or investigational device exemption (IDE), and misbranded because it failed to provide the required section 510(k) notification of intent to introduce the device into commercial distribution. The FDA had not authorized the HIV DBS kit for any use and found the company was actively offering the product for sale to individuals through its website for self-collection and laboratory testing.