Search Results

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.

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.

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.

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.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in senum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxfLx® analyzer.

The INNOFLUOR™ Topiramate Assay System consists of three products that are packaged and sold separately: the INNOFLUOR™ Topiramate Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR™ Topiramate Control Set. It is a fluorescence polarization immunoassay.

The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quantitative determination of total topiramate in serum or heparinized plasma by fluorescence polarization immunoassay. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® (TDx or TDxFLx®) analyzer. The INNOFLUOR™ Topiramate Reagent Set is intended for the quantitative determination of total topiramate in serum or heparinized plasma. The reagent set is intended for use in the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Calibrator Set is intended for use in the calibration of the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Reagent Set and Calibrator Set are used together to generate the calibration curve on the TDx or TDxFLx® analyzer. The calibration curve must be established prior to assaying unknown samples. Prior to performing the calibration procedure, the correct analyzer operating parameters must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR™ Topiramate Reagent Set. The INNOFLUOR™ Topiramate Control Set is intended for use in the quality control of the INNOFLUOR™ Topiramate Assay System. The Controls have been selected to best monitor the quality and stability of the calibration curve. The control results must be within established acceptable ranges before patient samples are assayed.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay for the quantitative determination of total topiramate in serum or heparinized plasma. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.

The INNOFLUOR™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay. The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.

Not Found