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The GenBody COVID-19 Ag Home Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of 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. ยง 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.