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510(k) Data Aggregation

    K Number
    K090964
    Device Name
    BINAXNOX STAPHYLOCOCCUS AUREUS TEST
    Manufacturer
    BINAX, INC.
    Date Cleared
    2009-12-16

    (254 days)

    Product Code
    JWX
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
    Device Description
    The BinaxNOW" Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures which have been identified as being positive for Gram-positive cocci in clusters. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device. Specimens are aliquots from blood cultures which have been identified as positive for Gram-positive cocci in clusters. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.
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    K Number
    K972030
    Device Name
    STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-09-08

    (98 days)

    Product Code
    JWX
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
    Device Description
    Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests.
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    K Number
    K964315
    Device Name
    REMEL STAPH LATEX KIT
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1997-02-07

    (101 days)

    Product Code
    JWX
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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