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Amplicon Land, LLC was warned for selling the "QuikPacII COVID-19 IgG/IgM Test" without FDA marketing approval, clearance, or authorization, making the product adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company also violated section 502(o) by failing to notify FDA of its intent to introduce the device into commercial distribution as required under section 510(k). The unapproved COVID-19 test kit was being marketed and offered for sale on the company's websites (ampliconexpress.com and amplicondist.com) in violation of federal law prohibiting introduction of such devices into interstate commerce.