Celltrion Diatrust COVID-19 Ag Rapid Test

*CLIA CARD/CERTIFICATE REQUIRED FOR PURCHASE

*FOR USE UNDER THE EMERGENCY USE AUTHORIZATION (EUA) ONLY

FOR IN VITRO DIAGNOSTIC USE

FOR PRESCRIPTION USE ONLY

• Nasopharyngeal Swab Sample (NPS)
• Fast and Precise Result in 15 Minutes
• 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

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.

• 25 test devices
• 25 swabs
• 25 extraction buffer
• 25 filter caps
• 1 positive control swab
• 1 negative control swab
• 1 Quick Reference Instruction