United Arab Emirates Firm Draws Warning for At-Home COVID-19 Test

July 2, 2020

The FDA has issued a warning letter to United Arab Emirates-based Antibodiescheck.com for marketing an at-home serology test for COVID-19 that the agency said is adulterated and misbranded.

The Antibodies Test Kit for COVID-19, manufactured by China-based Hotgen Biotech, was offered for sale in the U.S. without marketing approval, clearance or authorization from the FDA.

The FDA noted the website included instructional videos on how to self-administer the test and interpret test results. The agency has not approved any COVID-19 tests for at-home use.

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