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OraSure Technologies InteliSwab™ COVID-19 Rapid Test Pro Kit Controls
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Catalog No. 23222114 Shop All OraSure Technologies Products
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For Use With (Equipment):
InteliSwab™ COVID-19 Rapid Test Pro
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Catalog No. For Use With (Equipment)
23-222-114 InteliSwab™ COVID-19 Rapid Test Pro
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Catalog No. 23-222-114 Supplier OraSure Technologies Supplier No. 10010613
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Description

External quality control reagents to monitor the performance of InteliSwab™ COVID-19 rapid test pro with direct anterior nasal samples

  • For use only with InteliSwab™ COVID-19 Rapid Test Pro
  • Kit control box contains:
    • Instructions for use (IFU)
    • Specimen collection loops
    • Two vials:
      • One COVID-19 positive control
      • One COVID-19 negative control

Specifications

Content And Storage 36°F to 46°F
Detectable Analytes SARS-CoV-2 Nucleocapsid Protein Antigen
For Use With (Equipment) InteliSwab™ COVID-19 Rapid Test Pro
Type InteliSwab™ Kit Controls
Includes Instructions for use, Specimen collection loops, COVID-19 positive control, COVID-19 negative control

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. 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.

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