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    K Number
    K051456
    Device Name
    SENTINEL CERULOPLASMIN
    Manufacturer
    SENTINEL CH. SRL
    Date Cleared
    2005-10-21

    (141 days)

    Product Code
    JFR
    Regulation Number
    866.5210
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    Product Code :

    JFR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.
    Device Description
    Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.
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