FDA Authorizes the First Molecular Over-the-Counter COVID-19 Test

Cue Medical COVID-19 Test is available over-the-counter for people with or without COVID-19 symptoms

If your email program has trouble displaying this email, view as a webpage. COVID-19 Update: FDA Authorizes the First Molecular Over-the-Counter At-Home Diagnostic Test for COVID-19 Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that: Can be used completely at home without a prescription by people with or without COVID-19 symptoms.  Requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Delivers results in about 20 minutes. The test, which is performed using the Cue Sample Wand, is for:  Adults, using a self-collected nasal sample, or Children age two and older, using a nasal sample collected by an adult. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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