# FDA WARNING_LETTER - antibodiescheck.com - June 15, 2020

Source: https://www.keypedia.com/records/warning_letter/antibodiescheckcom/c5c759d2-bc85-427e-9250-cc4a7cc7f61c

> FDA WARNING_LETTER for antibodiescheck.com on June 15, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: antibodiescheck.com
- Inspection Date: 2020-06-15
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On June 15, 2020, the FDA issued a Warning Letter to Beijing Hotgen Biotech Co., Ltd. regarding their "Antibodies Test Kit for Covid19" (aka “Corona Check Kit,” “Antibodies Check Kit,” “Covid-19 IgG/IgM Rapid Test Cassette (WB/S/P),” and “Corona Antibodies Test”), offered for sale on www.antibodiescheck.com. The FDA determined this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the agency of intent to introduce the device into commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 3

## Related Officers

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

Company: https://www.keypedia.com/companies/antibodiescheckcom/29fe88a5-db65-4cf7-aaeb-d794abb7aaaa

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