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510(k) Data Aggregation

    K Number
    K050113
    Device Name
    TINA-QUANT IGG GEN.2
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2005-02-08

    (21 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF.
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    K Number
    K040434
    Device Name
    ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2004-03-10

    (20 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidimetric assay for the quantitative in vitro determination of IgG 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 IgG Gen.2 is an immunoturbidimetric assay. Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
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    K Number
    K010617
    Device Name
    SPIFE IFE CALIBRATOR AND CONTROL KIT
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2001-03-15

    (14 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993928
    Device Name
    WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2000-01-18

    (61 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurer agnosis . Qid body's metabolism and for agents. Associates to vesist infectious
    Device Description
    The Wako IgG II - HA test is an in vitro assay for the quantitative determination of immunoglobulin G in serum. When a sample is mixed with the Buffer solution and Anti-IgG, IgG in the sample combines specifically with anti-human IgG antibody in the Anti-IgG to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgG in the sample.
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    K Number
    K993281
    Device Name
    K-ASSAY IGG
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-09

    (40 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY IgG Assay is intended to be used for the quantitative determination of IgG in human serum by immunoturbidimetric assay. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K983221
    Device Name
    IGG
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-11-04

    (51 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G 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 G in the sample.
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    K Number
    K963974
    Device Name
    IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-03-06

    (155 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quartitative determination of Immunoglobulin G in urine by rate nephelometry.
    Device Description
    The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in coniunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.
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    K Number
    K965108
    Device Name
    SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-03-06

    (76 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with dinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
    Device Description
    The SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.
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    K Number
    K963868
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-02-10

    (137 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry. The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry. The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.
    Device Description
    The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.
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    K Number
    K962202
    Device Name
    QUANTEX IGG
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1996-09-26

    (111 days)

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

    DEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    quantex IgG: 8 x 6 mL anti-human IgG P/N 3000-22134; 2 x 100 mL Buffer P/N 3000-22130
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