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FDA authorizes first over-the-counter home Coronavirus test

FDA authorizes first over-the-counter home Coronavirus test
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FDA Authorizes Over the Counter At-Home Antigen Test

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Source: AP Photo/Taimy Alvarez
On Tuesday the Food and Drug Administration issued an emergency use authorization for the first over-the-counter fully at-home COVID-19 diagnostic test. The Ellume COVID-19 Home Test is a nasal swab that can be taken by anyone 2 years or older. It is the first COVID test that can be used completely at home without a prescription, the FDA explains.
Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product, when used for diagnosing COVID-19, outweigh the known and potential risks of such product, FDA Chief Scientist Denise M. Hinton wrote in a letter to Ellume Limited s Myriam Battistutta. ....

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