Description

The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus, delivering results in just 10 minutes. 

Features

• Rapid results in 10 minutes
• Approved 18 month shelf life
• User-friendly instructions
• Lightweight packaging for easy travel

Kit Contents

• (2) Test cassettes
• (2) Buffer solution vials
• (2) Shallow nasal swabs
• Quick Reference Instructions

Performance Measures

• 89.8% Sensitivity
• 99.8% Specificity

Disclaimer

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. 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 Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.