Sienna COVID-19 Antigen Rapid Test Kit
The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette has not been FDA cleared or approved; nonetheless, FDA has authorized this test for use by laboratories having a CLIA Certificate of Waiver under an EUA.
This test is exclusively approved for the identification of SARS-CoV-2 proteins, not for any other viruses or diseases.
Unless the declaration is terminated or the authorization is revoked sooner, this test 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).
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