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Blackfly Investments, LLC dba Molecular® Testing Labs was warned for offering an HIV serological diagnostic dried blood spot (DBS) card self-collection kit for sale in the United States without required marketing authorization. The company's product violated the Federal Food, Drug, and Cosmetic Act by lacking either an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE), rendering the device adulterated and misbranded under FDA regulations. The FDA identified these violations through review of the company's website, previous correspondence, and submitted materials, determining the kit was being distributed directly to individuals for self-collection of samples without proper regulatory clearance.