# FDA WARNING_LETTER - Biopolygen Corp. - August 10, 2021

Source: https://www.keypedia.com/records/warning_letter/biopolygen-corp/38e2c863-9711-4d66-81fd-e1fe988f3625

> FDA WARNING_LETTER for Biopolygen Corp. on August 10, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Biopolygen Corp.
- Inspection Date: 2021-08-10
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 9, 2021, the FDA issued a Warning Letter to Biopolygen after reviewing their website on January 7, February 26, and June 30, 2021. The FDA observed the sale of "COVIGEN AG-1 Covid-19 Self Detection Kit," "COVIDEX AB-1 Covid-19 Self Detection Kit," and "COVID-19 Antigen and Antibody Combo Set" (collectively, "COVID-19 Self Detection Test Kits").

These products are considered devices under section 201(h) of the Act, 21 U.S.C. § 321(h), as they are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because Biopolygen lacks approved applications for premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failing to notify the FDA of their intent to introduce the devices into commercial distribution, as required by section 510(k) of the

## Related Officers

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

Company: https://www.keypedia.com/companies/biopolygen-corp/8f0968f7-562a-4eb6-88fe-37bbf003f906

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