Celltrion DiaTrust COVID-19 Ag Rapid Test Save On LLC

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.

• For use under Emergency Use Authorization Only.
• For in vitro diagnostic use only.
• For prescription use only.
• Read all instructions completely and carefully and follow all instructions. Failure to follow all instructions may result in inaccurate test results.
• This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
• 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 diagnostic tests 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 the authorization is revoked sooner.
• Use appropriate precautions in the collection, handling and storage of patient samples. Refer to CDC Interim Guidelines for Collection, Handling and Transportation of clinical specimens from persons with Coronavirus Disease 2019 (COVID-19) at https:///coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html, and to WHO’s Interim guidance for Laboratory testing for coronavirus disease (COVID-19) in suspected human cases at http:///s/files/1/0417/2270/8131/files/pdf-icon_min.jpg?v=1602710293″ style=”vertical-align:sub;margin-right:5px;width:20px”> Brochure