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510(k) Data Aggregation

    K Number
    K070486
    Device Name
    CAPILLARYS URINE (PN 2012)
    Manufacturer
    Sebia, Inc.
    Date Cleared
    2007-12-21

    (304 days)

    Product Code
    JKM
    Regulation Number
    866.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sebia, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K042939
    Device Name
    CAPILLARY'S IMMUNOTYPING (PN 2100)
    Manufacturer
    Sebia, Inc.
    Date Cleared
    2005-06-27

    (245 days)

    Product Code
    DFH, CEF, CFF, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sebia, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 or CAPILLARYS ß1-S2" kits designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9). Identification of Monoclonal immunoglobulins is essential for the classification of monoclonal gammopathies by the class and type of involved immunoglobulins. "For In Vitro Diagnostic Use."
    Device Description
    The CAPILLARYS system performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each sample is mixed with individual antisera that are specific against gamma (IgG), alpha (IgA) and mu (IgM) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains. The proteins fractions, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually by comparing the profile of the untreated sample with the individual profiles treated with the respective antisera. Monoclonal immunoglobulins are thus detected and identified.
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