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    K Number
    K021687
    Device Name
    BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
    Manufacturer
    BINAX, INC.
    Date Cleared
    2002-09-13

    (114 days)

    Product Code
    GQG
    Regulation Number
    866.3480
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Binax NOW® RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash specimens from symptomatic patients. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results be confirmed by cell culture.

    Device Description

    Not Found

    AI/ML Overview

    The provided text only contains an FDA 510(k) clearance letter for the Binax NOW® RSV Test. This letter confirms substantial equivalence to a predicate device and outlines regulatory information. It does not contain details about specific acceptance criteria for performance, nor does it describe a study proving the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical study details.

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