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Cue COVID-19 Test Kit OTC For Home and Over The Counter (OTC) Use 10/Bx

Cue C2020 COVID-19 Test Kit

Laboratory / Molecular Testing / 1403062 | CUE HEALTH, INC. - C2020
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  9. Cue COVID-19 Test Kit OTC For Home and Over The Counter (OTC) Use 10/Bx
Cue COVID-19 Test Kit OTC For Home and Over The Counter (OTC) Use 10/Bx
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Descripción del producto Resumen de las funciones del producto

  • • The Test Kits have not been FDA cleared or approved.
  • • The Test Kits have been authorized by the FDA under an EUA for non-prescription home use.
  • • Emergency use of these Test Kits 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • • The Test Kits have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.LI>

    • Especificaciones Especificaciones y medidas de los productos

    • Brand
      Cue
    • CLIA Classification
      OTC
    • For
      Home and Over The Counter (OTC) Use
    • Item
      Test Kit
    • Item Type
      COVID-19

    Productos suplentes (1) Este producto no se encuentra disponible. Vea los productos suplentes a continuación:

    Description du catalogue Tal como se ve en nuestro catálogo impreso

    The Cue™ COVID-19 Test is a molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. Intended for use in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. Authorized for nonprescription home use. Utilizes isothermal nucleic amplification technology. Must be used with the Cue Health Monitoring System (Cue Cartridge Reader) and the Cue Health Mobile App.

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