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510(k) Data Aggregation

    K Number
    K153538
    Device Name
    Dextramer CMV Kit
    Manufacturer
    Date Cleared
    2017-03-02

    (448 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    Immudex Aps

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry. Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings. The kit cannot be used to measure CMV infection or disease. The kit is limited to individuals with the following HLA types: A*0101, A*0201, B*0702, B*0801, B*3501. Special instrument requirements: FACSCanto II flow cytometer (Becton Dickinson).
    Device Description
    The Dextramer® CMV Kit comprises 5 CMV Dextramers, Negative control as well as 3 antibodies recognizing CD3, CD4, and CD8. The Dextramer® CMV Kit accurately enumerates CMV-specific T cells in blood samples. This involves a two-step procedure followed by analysis by flow cytometry: Step 1: Determination of the percentage of CMV-specific CD3*CD8* T cells in the sample (Tube A) Step 2: Determination of the absolute number of CD3*CD8* T-cells in the sample (Tube C) The absolute number of CMV-specific CD3*CD8* T cells/ul blood is then determined.
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