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Block Scientific was warned for selling two unapproved COVID-19 diagnostic test kits—the QUIKPACII COVID-19 Antibody Test Kit and the Long Island Biotech COVID-19 Antigen Rapid Test—without FDA marketing approval, clearance, or authorization. The products violated the Federal Food, Drug, and Cosmetic Act by lacking required premarket approval (PMA) or investigational device exemption (IDE), and the company failed to submit the required section 510(k) notification before introducing the devices into commercial distribution. These violations rendered the products both adulterated and misbranded, making their introduction or delivery into interstate commerce prohibited under federal law.