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BinaxNOW COVID-19 Antigen Antigen Self Test CLIA Exempt 12Kts/Ca

BinaxNOW 195-264 COVID-19 Antigen Antigen Self Test

Laboratory / Rapid Diagnostic Test Kit / 1418313 | Abbott Rapid DX N.America LLC - 195-264
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  9. BinaxNOW COVID-19 Antigen Antigen Self Test CLIA Exempt 12Kts/Ca
BinaxNOW COVID-19 Antigen Antigen Self Test CLIA Exempt 12Kts/Ca
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  • Categoría:
    Laboratory / Rapid Diagnostic Test Kit / Respiratory
  • UNSPSC:
    41116100

Descripción del producto Resumen de las funciones del producto

  • • This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; LI>
  • • 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

    • Especificaciones Especificaciones y medidas de los productos

    • Additional Attributes
      OTC SELF TESTING
    • Brand
      BinaxNOW
    • CLIA Classification
      CLIA Exempt
    • Item
      Antigen Self Test
    • Item Type
      COVID-19 Antigen
    • Secondary Size
      2 Test/Kit

    Description du catalogue Tal como se ve en nuestro catálogo impreso

    A lateral-flow immunochromatographic assay for the detection of nucleocapsid protein antigens specific to SARS-CoV-2. Uses anterior nasal swab specimens self collected by individiuals 15 or older or collected by an adult from an individual aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for indivudals without symptoms or other epidemiological reasons to suspect COVID-19, when tested three times over five days with at least 48 hours between tests.

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