Celltrion DiaTrust™ COVID-19 Ag HomeTest (OTC)

Description

• DiaTrust COVID-19 Ag Home Test Fact Sheet for HCP
• DiaTrust COVID-19 Ag Home Test IFU
• DiaTrust COVID-19 Ag Home Test IFU for HCP
• DiaTrust COVID-19 Ag Home Test Box Labels

• 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 ot
  her viruses or pathogens; and,
• The emergency use of this product is only authorized for the duration of the declaration that circums
  tances 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.