FDA WARNING_LETTER - antibodiescheck.com - June 15, 2020

On June 15, 2020, the FDA issued a Warning Letter to Beijing Hotgen Biotech Co., Ltd. regarding their "Antibodies Test Kit for Covid19" (aka “Corona Check Kit,” “Antibodies Check Kit,” “Covid-19 IgG/IgM Rapid Test Cassette (WB/S/P),” and “Corona Antibodies Test”), offered for sale on www.antibodiescheck.com. The FDA determined this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the agency of intent to introduce the device into commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 3