*Abbott conducted a computational analysis of the detection of multiple SARS-COV-2 strains, including the Delta and Omicron variants, and predicts no impact to the performance of our BinaxNOW COVID-19 Antigen Self Test.
This test does NOT meet the CDC testing requirements to enter the U.S. when returning from a trip abroad. The self-test is indicated for children as young as 2 years old when samples are collected by an adult, and for all people 15 and older. The BinaxNOW™ COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. BinaxNOW™ COVID-19 Antigen should be performed twice over 3 days, at least 24 hours (but no more than 48 hours) apart. For symptomatic use, a single test can be used. © 2021 Abbott. All rights reserved. BinaxNOW is a trademark of Abbott and used with permission. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model.
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