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Lepu Medical Gets FDA Warning Letter for Unapproved COVID-19 Tests

August 12, 2021

The FDA has issued a warning letter to Lepu Medical Technology-Beijing for marketing three unauthorized COVID-19 tests.

The agency cited the company for marketing its Neutralization Antibody Test kit (a colloidal gold, fluorescent, ELISA test), a SARS-CoV-2 Antigen Rapid Test Kit (a colloidal gold immunochromatography test) and a Saliva Antigen Rapid Test.  

The agency noted that the products are subject to detention and refusal of admission if they are offered for importation into the United States and that it may advise local regulatory authorities that the products can’t be legally sold in the U.S.

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