GenBody COVID-19 Rapid Antigen Tests (GENB-COVAG025-NU-1) *CLIA Certificate Required* (GENB-COVAG025-NU-1)

GenBody COVID-19 Rapid Antigen Tests, (25 Tests per Kit, Includes Controls)

**Required CLIA Certificate for purchase**

The Genbody COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens. Rapid detection of SARS-CoV-2 will play a key role in the global spread of the virus.  An affordable and sensitive test this test does not require an additional reader and has a processing time of 15-20 minutes. Collection tube is pre-filled for convenience.

• Time to results in 15-20 mins
• Collection Method: Anterior Nasal
• For use under an Emergency Use Authorization (EUA) Only
• For in vitro diagnostic use only
• For professional use only

• Letter of Authorization

  "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 "