The Sienna COVID -19 Rapid Antigen Test
is a 10 Minute Point of Care (POC) Rapid Antigen Test created for the qualitative detection of COVID-19 antigen. It is intended to aid in the rapid diagnosis of COVID-19 infections.
The Sienna nasal swab test kit is a point-of-care immunodiagnostic test that can be administered anywhere, does not require samples to be sent to a lab and delivers a result in ten minutes.
This test is an affordable, cost-effective solution, perfect for screening large groups of individuals.
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; 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.
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