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510(k) Data Aggregation

    K Number
    K092283
    Device Name
    DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2009-10-21

    (84 days)

    Product Code
    DFZ
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    DFZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings. The IGG2 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 2 in human serum. heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings. The IGG3 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings. The IGG4 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findinas.
    Device Description
    Dimension Vista® IGG 1-2 Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration. Dimension Vista® IGG 3-4 Flex® reagent cartridge: Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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    K Number
    K021081
    Device Name
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2002-06-17

    (75 days)

    Product Code
    DFZ, DEZ
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    DFZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer
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    K Number
    K020823
    Device Name
    PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
    Manufacturer
    SANQUIN BLOOD SUPPLY FOUNDATION
    Date Cleared
    2002-05-14

    (61 days)

    Product Code
    DFZ
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    DFZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE® Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.
    Device Description
    Sheep antibodies to human IgG subclasses with the four subclasses of human IgG immunoglobulins, forming immuno-precipitates. This reaction consequently causes changes in the intensity of scattered light at a rate that increases gradually at first, then rapidly and finally proceeds through a peak rate of change (peak rate value) for the component being analyzed.
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    K Number
    K955906
    Device Name
    BOEHRINGER MANNHEIM IGG ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-02-09

    (42 days)

    Product Code
    DFZ
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    DFZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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