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InteliSwab COVID-19 PRO Test Kit CLIA Waived 25/Bx

InteliSwab 1001-0614 COVID-19 PRO Test Kit

Laboratory / Rapid Diagnostic Test Kit / 1405906 | Orasure Technologies - 1001-0614
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  9. InteliSwab COVID-19 PRO Test Kit CLIA Waived 25/Bx
InteliSwab COVID-19 PRO Test Kit CLIA Waived 25/Bx
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Product Overview Product feature summary

  • • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
  • • Authorized laboratories include those certified under CLIA that meet the requirements to perform moderate, high or waived complexity tests. The test is authorized for use in point of care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
  • • 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. LI>

    • Specifications Product specifications and dimensions

    • Brand
      InteliSwab
    • CLIA Classification
      CLIA Waived
    • Item
      Test Kit
    • Item Type
      COVID-19 PRO

    Catalog Description As seen in our print catalog

    These single-use, lateral flow immunoassays with integrated swabs are intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal samples from individuals 18 years or older when the sample is self-collected, or in individuals 2 years or older when the sample is collected by an adult. The test is authorized for individuals who are suspected of having COVID-19 by their health-care provider within 7 days of symptom onset or for use serially from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over 2 or 3 days with at least 24 hours and no more than 48 hours between tests.

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