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Share this article Share this article SAN DIEGO, April 5, 2021 /PRNewswire/ Cue Health Inc. ( Cue ), a healthcare technology company, today announced Cue for Schools, a COVID-19 on-site testing solution for K-12 schools and universities that uses the Cue Health Monitoring System and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, the nation s first molecular diagnostic test available without a prescription with Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Cue s easy-to-use, portable COVID-19 test provides lab-quality results directly to connected mobile smart devices in about 20 minutes and Cue s natively digital platform allows for end-to-end integrated reporting to meet both state and federal reporting standards. Cue s OTC COVID-19 test can be administered by anyone, anywhere making it easy for schools to utilize. As part of the Cue for Schools program, schools will receive customized on-site or virtual support ....
FDA issues authorization for first molecular non-prescription, at-home COVID-19 test outbreaknewstoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from outbreaknewstoday.com Daily Mail and Mail on Sunday newspapers.
FDA authorizes first molecular non-prescription, at-home COVID-19 test news-medical.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from news-medical.net Daily Mail and Mail on Sunday newspapers.
Share this article Share this article SILVER SPRING, Md., March 5, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. The authorization of this new diagnostic test underscores FDA s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans, said Acting FDA Commissioner Janet Woodcock, M.D. The FDA will continue to expand Americans access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States. ....