# FDA WARNING_LETTER - USH Diagnostics, Inc./covidinstanttest.net - April 09, 2021

Source: https://www.keypedia.com/records/warning_letter/ush-diagnostics-inccovidinstanttestnet/ed292823-09a6-4c20-ab67-be7bc0db5b60

> FDA WARNING_LETTER for USH Diagnostics, Inc./covidinstanttest.net on April 09, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: USH Diagnostics, Inc./covidinstanttest.net
- Inspection Date: 2021-04-09
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 9, 2021, the FDA issued a Warning Letter to covidinstanttest.net and ushealthdiagnostics.com for offering unapproved and misbranded COVID-19 Test Kits. The FDA reviewed their websites and social media on March 30 and April 9, 2021, identifying products like the "Rapid Dual Antibody Test," "Rapid 10 Minute Antigen Test," and "Saliva Test Kit" for at-home COVID-19 testing.

These products are deemed devices under the Federal Food, Drug, and Cosmetic Act (the "Act") and are adulterated under section 501(f)(1)(B) because the firm lacks premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failing to notify the FDA of intent to introduce devices into commercial distribution (510(k) requirement). Furthermore, the products are misbranded under section 502(a) due to misleading claims of "FDA Submitted/EUA Approved," "FDA EUA Authorized," or "EUA/FDA Certified," and unauthorized use of the FDA logo, implying endorsement.

The FDA requires immediate cessation of sales for all unapproved, uncleared, and unauthorized COVID-19 products. The firm must email COVID-19-Task-Force-CDRH@fda.hhs.gov within 4

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/ush-diagnostics-inccovidinstanttestnet/f22972bb-f5a7-4872-874e-1a0c04b353ff

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7