In the United States: This test has not been FDA cleared or approved. This tests has been authorized by FDA under an EUA for use by authorized laboratories. Xpert Xpress CoV-2/Flu/RSV plus has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens. The emergency use of this product is 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.
CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.