This test does NOT meet the CDC testing requirements to enter the U.S. when returning from a trip abroad.
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 Self Test should be performed twice in 3 days, at least 36 hours apart. © 2021 Abbott. All rights reserved.
Some or all of the cost of your COVID rapid tests may be reimbursable by your health insurance, please reach out to them directly or visit the Center for Medicare & Medicaid Services's website (www.CMS.gov) for more information.