> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Company Selling Unapproved Covid Test: FDA
- URL: https://www.fdaweb.com/company-selling-unapproved-covid-test-fda/
- Published: 2021-05-11T12:00:00.000Z
- Updated: 2026-09-14T16:58:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149293

FDA says the Web site maintained by Anytime Covid Test LLC, Boynton Beach, FL, indicates the firm is marketing a direct-to-consumer Covid-19 test kit that is legally considered a medical device. A just-released 4/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/anytime-covid-test-llc-611366-04132021?ref=fdaweb.com) says the kit is being offered without marketing approval, clearance, or authorization from FDA and thus is adulterated. The kit also is misbranded, the agency says, because Anytime did not notify the agency of its intent to introduce the product into commercial distribution.

The company was told to take immediate steps to address the violations cited in the letter and to respond by e-mail with a list of specific steps it has taken and related documentation.