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Clarity COVID-19 Antigen Rapid Test

$214.00 $225.00

SKU: CLA-COV19AG-VIS

Description

Clarity-COVID-19-Antigen-Rapid-Test-brochure

Kit includes

  • 25 Individually pouched test cassettes
  • 25 Sterile naso-pharyngeal swabs
  • 25 Buffer tubes
  • 1 Negative control swab
  • 1 Positive control swab
  • 1 Workstation
  • 1 Package insert (instructions for use)
  • 1 Quick start guide

The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories operating minimally with a CLIA Certificate of Waiver. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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), unless the declaration is terminated or authorization is revoked sooner.

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