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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.

The agency’s Center for Devices and Radiological Health submitted warnings recently to Trask and Roth Inc., Tempe, AZ; LVWellness &...

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