This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and
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.
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