CLARITY COVIBLOCK RAPID TEST CASSETTES

  • The Clarity COVIBLOCK COVID-19 Rapid Test Cassettes is an in vitro, rapid, qualitative immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in Whole blood ( Fingerstick and Venous) , Plasma or Serum.

  • The Clarity COVIBLOCK COVID-19 Rapid Test Cassette used with fingerstick whole blood specimen is currently classified as CLIA Waived, and authorized for use at Point of Care (POC) settings under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

  • This test is only provided for use in laboratories or by healthcare workers at the point-of-care.

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CLARITY COVIBLOCK COVID-19 RAPID TEST CASSETTES

  • Combined Sensitivity 93.3%

  • Combined Specificity 98.8%

  • 95% overall accuracy

  • Use Whole Blood, Plasma or Serum

  • Fast & easy (with positive results as fast as 10 minutes)

  • Room temperature storage

PRODUCT CODES

  • CD-COV19 (49/CASE, 20/BOX)

    • Contains: Covid19 Test Cassettes. Buffer Solution. Disposable Pipettes. Lancets. Alcohol Swabs. Package Insert.

  • CD-COV19-GMCTL

    • Contains: 1 Positive Control and 1 Negative Control

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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