COVID-19 Ag Home Test
The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under
Emergency Use Authorization (EUA) only. 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. 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.