COVID Antigen Test by Celltrion DiaTrust

 Celltrion Brand Rapid COVID Antigen Test

Intended Use

A rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor-binding domains (RBDs) from the SARS-CoV2 in human nasopharyngeal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988.

• For use under the Emergency Use Authorization (EUA) only
• For in vitro diagnostic use
• For Prescription Use only

Sample Type:

Nasopharyngeal Swab Sample (NPS)

Storage 

Result Wait Time

15 minutes

Included Contents

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

Acceptable Use

For Point of Care Use (By laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests).

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