The Cue COVID-19 Test for Home and Over The Counter (OTC) Use, the Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories, and the Cue Mpox (Monkeypox) Molecular Test have not been FDA cleared or approved, but they have been authorized for emergency use by the FDA under Emergency Use Authorizations (EUAs). These products have been authorized only for the detection of nucleic acid from SARS-CoV-2 or monkeypox virus, respectively, not for any other viruses or pathogens. The emergency use of these products is only authorized for the duration of the declarations that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with COVID-19 or the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the relevant declaration is terminated or authorization is revoked sooner.
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