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USH Diagnostics, Inc. was warned for selling COVID-19 test kits (antibody tests, antigen tests, and saliva tests) without FDA authorization, making these products adulterated and misbranded medical devices. The company marketed and sold these tests through their websites (covidinstanttest.net and ushealthdiagnostics.com) and social media channels as diagnostic tools for COVID-19 mitigation, prevention, treatment, diagnosis, or cure, despite lacking required FDA clearance or emergency use authorization. The FDA conducted website reviews in March and April 2021 and determined the test kits were intended for medical use but were not properly regulated under the Federal Food, Drug, and Cosmetic Act.