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COVID-19 Tests Sold OTC By US Doctors Need Approval

 
• By Malcolm Spicer

Center for Devices and Radiological Health submitted warnings recently to Trask and Roth, LVWellness & Aesthetics and Physician 360  about a variety of tests offered for sale directly to consumers and promoted as detecting COVID-19 infections.

At-home tests to detect COVID-19, like any product currently available directly to consumers, aren’t approved in the US, the Food and Drug Administration informs health care and device providers in warning letters.

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