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BinaxNOW COVID-19 Ag Card CLIA Waived 40/Bx

BinaxNOW 195-000 COVID-19 Ag Card

Laboratory / Rapid Diagnostic Test Kit / 1402983 | Abbott Rapid DX N.America LLC - 195-000
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  9. BinaxNOW COVID-19 Ag Card CLIA Waived 40/Bx
BinaxNOW COVID-19 Ag Card CLIA Waived 40/Bx
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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.

  • • This product has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Page 3 of 14 Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high or waived complexity tests.

  • • This test is also authorized for use at Point of Care (POC), i.e., in patient 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.

  • • 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

  • Brand
    BinaxNOW
  • CLIA Classification
    CLIA Waived
  • Item
    Card
  • Item Type
    COVID-19 Ag

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 directly collected from individuals who are suspected of having COVID-19 by their health-care provider within the first 7 days of symptom onset, when tested at least twice over three days with at least 48 hours between tests or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests.

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