CLARITY COVID-19 ANTIGEN RAPID TEST CASSETTES

  • FDA Emergency Use Authorized, CLIA Waived and POCT approved.

  • Relative Sensitivity 87.5%

  • Relative Specificity: >98.9%

  • Fast and Easy – Positive results as fast as 5 minutes

  • Test Naso-Pharyngeal Swab immediately, or store at room temperature and test within 1 hour.

  • Naso-Pharyngeal Swab stored in a dry tube at 2-8c can be tested within 24 hours.

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  • IMPORTANT INFORMATION

  • This test is not approved for OTC use or At-Home use.

  • The Clarity COVID-19 Antigen test can be used to test directly collected naso-pharyngeal swab specimens.

  • The Clarity COVID-19 Antigen test should be ordered for the detection of COVID-19 antigen in individuals who are suspected of COVID-19 by their healthcare provider and who are within six days of symptom onset.

  • The Clarity COVID-19 Antigen test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity, moderate complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.  Our CLIA Waiver can be found on the FDA’s website at the following link: https://www.fda.gov/media/149056/download

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    • In the USA, 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; and,

    • 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

    • For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

    • For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19