# FDA WARNING_LETTER - AkivaMed Inc. - July 08, 2020

Source: https://www.keypedia.com/records/warning_letter/akivamed-inc/52cdf197-0ff8-4977-bf17-32180acc4779

> FDA WARNING_LETTER for AkivaMed Inc. on July 08, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: AkivaMed Inc.
- Inspection Date: 2020-07-08
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 23, 2020, the FDA issued a Warning Letter to AkivaMed, following a July 8, 2020 review of their website, www.akivamed.com. The FDA observed that AkivaMed was offering a "COVID-19 Antibody Rapid Test Kit" for sale directly to consumers for at-home use in the United States.

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), as it is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

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

## Related Officers

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

Company: https://www.keypedia.com/companies/akivamed-inc/055bec7a-5fce-4998-9832-a17f1d072fb1

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