Celltrion DiaTrust™ COVID-19 Ag Home Test (Over the Counter Home Testing) 25T
Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 spike proteins in human nasopharyngeal swab specimen. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.
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|Dimensions||7.68 × 5.71 × 3.94 in|
- Sample Type | DIRECT MID-TURBINATE SWAB SAMPLES
- Sample-to-answer time | 15 minutes
- FDA Status | FOR USE UNDER THE EMERGENCY USE AUTHORIZATION (EUA) ONLY
- Authorized Setting | NON-PRESCRIPTION HOME USE (OTC)
Celltrion DiaTrust™ COVID-19 Ag Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and receptor binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2.
- 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,
- 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 Ac, 21 U.S.C. § 360bbb-3(b)(1), unless, the declaration is terminated or authorization is revoked sooner.