USH Diagnostics, Inc./covidinstanttest.net

Warning LetterOpen

Mr. Chris Ormiston USH Diagnostics, Inc./covidinstanttest.net 3456 E. 155th St. Kansas City , MO 64147 United States co@ushealthdiagnostics.com cormiston@ushealthdiagnostics.com support@covidinstanttest.netIssued Jul 9, 2021Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateJul 9, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: USH Diagnostics, Inc./covidinstanttest.net
Location: Mr. Chris Ormiston USH Diagnostics, Inc./covidinstanttest.net 3456 E. 155th St. Kansas City , MO 64147 United States co@ushealthdiagnostics.com cormiston@ushealthdiagnostics.com support@covidinstanttest.net
FEI Number: N/A
Country: United States
Issue Date: July 09, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Open

Summary

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.

USH Diagnostics, Inc./covidinstanttest.net FDA Warning Letter, July 9, 2021