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# Webstore-USA Marketing Unapproved Covid Serology Test: FDA
- URL: https://www.fdaweb.com/webstore-usa-marketing-unapproved-covid-serology-test-fda/
- Published: 2021-03-03T12:00:00.000Z
- Updated: 2026-09-14T16:49:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148792

FDA says its review of a Web site maintained by Orvic, doing business as Webstore-USAVan Nuys, CA, determined that the firm is marketing an unapproved Covid-19 serology test that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19, and thus is legally considered to be a medical device. “The product is offered for sale in the United States without marketing approval, clearance, or authorization from FDA,” a 2/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orvic-dba-webstore-usa-610208-02262021?ref=fdaweb.com) says. The letter says the test is adulterated because it does not have FDA approval, clearance, or authorization.

The letter also cites the potentially serious public health risks associated with specimen collection and testing in the home versus a healthcare setting.

Webstore-USA was told to take action to address the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each action and a schedule for completing the steps.

FDA also said the firm will be added to an agency Web site list of companies that have received Warning Letters for marketing unapproved Covid products.