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ID NOW COVID-19 2.0 Test Kit CLIA Waived 24/Bx

ID NOW 192-000 COVID-19 2.0 Test Kit

Laboratory / Molecular Testing / 1423598 | Abbott Rapid DX N.America LLC - 192-000
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ID NOW COVID-19 2.0 Test Kit CLIA Waived 24/Bx
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  • ID NOW COVID-19 2.0 Test Kit CLIA Waived 24/Bx 1423598 | Abbott Rapid DX N.America LLC - 192-000

  • Description:
    ID NOW COVID-19 2.0 Test Kit CLIA Waived 24/Box
  • Category:
    Laboratory / Molecular Testing
  • UNSPSC:
    41116100
  • Packaging Options (1)
    • Discontinued

Product Overview Product feature summary

Features & Benefits:

  • • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
  • • This product has been authorized only for the detection of nucleic acid 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. § 360bbb 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Specifications Product specifications and dimensions

  • Brand
    ID NOW
  • CLIA Classification
    CLIA Waived
  • Item
    Test Kit
  • Item Type
    COVID-19 2.0

Product Substitutes (1) This product is not available. See substitutes below:

Catalog Description As seen in our print catalog

ID NOW™ COVID-19 2.0 is a nucleic acid amplification test (NAAT), indicated for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal or nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. This isothermal molecular technology uses proprietary enzymes and constant temperature to achieve rapid amplification, with results in a fraction of the time it takes traditional molecular lab tests. Delivers reliable molecular results in just minutes, providing real-time access to the information needed to make actionable decisions right at the point of care. COVID-19 positive results in as early as 6 minutes; COVID-19 negative results in 12 minutes. PPA 93.3%, NPA 98.5%.

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