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510(k) Data Aggregation

    K Number
    DEN200067
    Device Name
    INNOVANCE VWF Ac
    Manufacturer
    Siemens Healthcare Diagnostics Products GmbH
    Date Cleared
    2022-09-29

    (701 days)

    Product Code
    QTY
    Regulation Number
    864.7293
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    Product Code :

    QTY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In-vitro diagnostic automated assay for the quantitative determination of the von Willebrand factor-GPIb-binding activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS XP System. As an aid used in the evaluation of patients with suspected or confirmed von Willebrand factor disorders. Results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other laboratory findings.
    Device Description
    The INNOVANCE VWF Ac assay is a particle enhanced turbidimetric assay based on binding of VWF to the recombinant GPIb (two gain-of-function mutations included). The assay provides quantitative VWF activity results on 3.2% citrated human plasma when used with Standard Human Plasma Calibrators (K023141). The reagent kit consists of three components: Reagent I (containing polystyrene particles coated with anti-GPIb mouse monoclonal antibodies). Reagent II (buffer containing heterophilic blocking reagent) and Reagent III (containing recombinant GPIb).
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