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Posted June 23, 2020

KBMO Diagnostics Warned for Unapproved COVID-19 Test

On June 17, the FDA issued a warning letter to KBMO Diagnostics, LLC for selling the product COVID-19 Fingerstick Test Kit, an unapproved, adulterated and misbranded antibody test for coronavirus (COVID-19). The agency also emphasized to consumers that there are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home.

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