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510(k) Data Aggregation

    K Number
    K193525
    Device Name
    Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
    Manufacturer
    Horiba ABX SAS
    Date Cleared
    2020-06-26

    (190 days)

    Product Code
    CZP, CFN, DEW, DFT
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Yumizen C1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other findings, Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin G (IgG) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other findings. Yumizen C1200 Immunoglobulin M reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin M (IgM) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
    This submission consists in the Yumizen C1200 Immunoglobulin A (1300023881), Yumizen C1200 Immunoglobulin G (1300023883) and Yumizen C1200 Immunoglobulin M (1300023884) reagent for serum and plasma testing for Yumizen C1200 reagent. The Yumizen C1200 Level 1 Protein Control (1300023944) and Yumizen C1200 Level 2 Protein Control (1300023945) for use on Yumizen C1200 Analyzer and the Yumizen C1200 Protein Cal (1300023893) for use on Yumizen C1200 Analyzer are sold separately.
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    K Number
    K060130
    Device Name
    IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2006-02-13

    (26 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IGALC reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.
    Device Description
    The IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin A in serum and cerebrospinal fluid.
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    K Number
    K040435
    Device Name
    ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2004-03-10

    (20 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidimetric assay for the quantitative in vitro determination of IgA in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    The Tina-quant IgA Gen.2 is an immunoturbidimetric assay. Anti-IgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
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    K Number
    K024038
    Device Name
    N LATEX IGA
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2003-02-13

    (69 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA aids in the evaluation of the patient's immune system.
    Device Description
    Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.
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    K Number
    K993927
    Device Name
    WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2000-01-14

    (57 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wako IgA II -- HA test is an in vitro assay for the quantitative determination of immunoglobulin A in serum.
    Device Description
    The Wako IgA II-HA test is a highly specific reagent based on turbidimetric immunoassay. When a sample is mixed with the Buffer solution and Anti-IgA, IgA in the sample combines specifically with anti-human IgA antibody in the Anti-IgA to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgA in the sample.
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    K Number
    K983359
    Device Name
    IGA
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-11-04

    (41 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Immunoglobulin A assay is used for the quantitation of immunoglobulin A in human serum or plasma. Measurement of immunoglobulin A aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.
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    K Number
    K962200
    Device Name
    QUANTEX IGA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1996-09-25

    (110 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product permits the quantitative in vitro diagnostic determination of Immunoglobulin A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    quantex IgA: 8 x 6 mL anti-human IgA P/N 3000-22133; 2 x 100 mL Buffer P/N 3000-22130
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    K Number
    K955794
    Device Name
    IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1996-04-05

    (105 days)

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

    CZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955907
    Device Name
    BOEHRINGER MANNHEIM IGA ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-02-09

    (42 days)

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

    CZP

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