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    K Number
    K111956
    Device Name
    KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2012-05-30

    (324 days)

    Product Code
    PAF
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    PAF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit is for the semiquantitative determination of antibodies to voltage gated calcium channels in human serum. The VGCC antibody may be present in patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS). The assay result is not to be used alone and is to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.
    Device Description
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