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In-Depth: The simple change that made rapid COVID tests reliable Over-the-counter rapid tests get FDA go-ahead The authorization from the FDA represents a significant endorsement that rapid diagnostics are accurate and effective in even the most challenging testing scenario: evaluating people who are not showing symptoms. and last updated 2021-04-01 21:26:05-04 SAN DIEGO (KGTV) -- COVID-19 self-tests that offer on-the-spot results in minutes will start hitting pharmacy shelves this month, with no prescription required. The Food and Drug Administration granted emergency authorization Wednesday...

Share this article Share this article SILVER SPRING, Md., March 31, 2021 /PRNewswire/ -- Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening te...

Abbott  announced today it has received U.S. Food and Drug Administration Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug and mass ...

Share this article Share this article ABBOTT PARK, Ill., March 31, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) announced today it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and expect the test to be availab...

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.