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510(k) Data Aggregation

    K Number
    K960702
    Device Name
    CRP-LATEX SEIKEN XR REAGENT SYSTEM
    Manufacturer
    GLOBE MANAGEMENT SUPPORT, INC.
    Date Cleared
    1996-04-19

    (59 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBE MANAGEMENT SUPPORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum on the Cobas Mira chemistry analyzer . Such measurements are used in the diagnosis and treatment of bacterial infections and inflammation.
    Device Description
    Are reagent systems for the quantitation of the concentration of CRP in human serum. Are based on the agglutination of CRP in serum with latex particles coated with anti-CRP. Employ the absorbance change observed as the basis for quantitation. Are intended for use with the Cobas Mira chemistry analyzer.
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    K Number
    K960703
    Device Name
    RF-LATEX SEIKEN REAGENT SYSTEM
    Manufacturer
    GLOBE MANAGEMENT SUPPORT, INC.
    Date Cleared
    1996-04-19

    (59 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBE MANAGEMENT SUPPORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.
    Device Description
    The RF-LATEX "SEIKEN" is a reagent system for the quantitation of the concentration of rheumatoid factor (RF) in human serum. It is based on the agglutination of RF in serum with latex particles coated with anti-RF (human IgG). It employs the absorbance change observed as the basis for quantitation and calculates the amount of RF by interpolation from a calibration curve prepared from calibrators of known concentration. It is intended for use with the Cobas Mira chemistry analyzer (or other suitable analyzer).
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