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    K Number
    K972331
    Device Name
    INNOFLUOR GENTAMICIN ASSAY SYSTEM
    Manufacturer
    OXIS INTL., INC.
    Date Cleared
    1997-08-01

    (39 days)

    Product Code
    LGQ
    Regulation Number
    862.3660
    Why did this record match?
    Product Code :

    LGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INNOFLUOR® Gentamicin Assay System is an in vitro diagnostic device intended for the quantitative determination of total Gentamicin in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer. The INNOFLUOR® Gentamicin Reagent Set is intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Gentamicin Assay System. The INNOFLUOR® Gentamicin Calibrator Set is intended for use in the calibration of the INNOFLUOR® Gentamicin Assay System.
    Device Description
    The INNOFLUOR® Gentamicin Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer. The system consists of the INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set, which are packaged and sold separately.
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    K Number
    K972330
    Device Name
    INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
    Manufacturer
    OXIS INTL., INC.
    Date Cleared
    1997-07-14

    (21 days)

    Product Code
    LGQ
    Regulation Number
    862.3660
    Why did this record match?
    Product Code :

    LGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device intended for the quantitative determination of total Phenobarbital in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer. The INNOFLUOR® Phenobarbital Reagent Set is intended for the quantitative determination of total phenobarbital in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Phenobarbital Assay System. The INNOFLUOR® Phenobarbital Calibrator Set is intended for use in the calibration of the INNOFLUOR® Phenobarbital Assay System.
    Device Description
    The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device used to monitor serum levels of the therapeutic, anticonvulsant drug, phenobarbital. It is a fluorescence polarization immunoassay based on the competitive binding principle. The system consists of two products: the INNOFLUOR® Phenobarbital Reagent Set (containing Phenobarbital Antibody, Phenobarbital fluorescein TRACER, and PRE TREATMENT BUFFER) and the INNOFLUOR® Phenobarbital Calibrator Set (containing human serum with added phenobarbital at various concentrations). The system is for use on the Abbott TDx® or TDxFLx® analyzer.
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