CELLTRION DIATRUST COVID-19 AG HOME TEST

Celltrion Ag Home Test EUA Letter from FDA

Celltrion Ag Home Test HCP Fact Sheet

Celltrion Ag Home Test IFU Instructions.

Celltrion Ag Home Test IFU

DiaTrust QRI

DiaTrust HCP

DiaTrust FS

DiaTrust IFU

DiaTrust Shelf Life Extension

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.