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FDA’s Center for Devices and Radiological Health

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COVID-19: FDA Approves First Rapid At-Home Test COVID-19: FDA Approves First Rapid At-Home Test
Covid-19: FDA Approves First Rapid At-Home Test The Food and Drug Administration has approved the first rapid at-home COVID-19 test that could have results returned within an hour. The FDA issued an emergency use authorization on Tuesday, Nov. 17 for the "Lucira COVID-19 All-In-One Test Kit," a single-use test that will detect the novel coronavirus SARS-CoV-2 that causes COVID-19. The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the S…

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by Zak Failla