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    K Number
    K091468
    Device Name
    IVD TECHNOLOGIES ACHRAB TEST KIT
    Manufacturer
    IVD TECHNOLOGIES
    Date Cleared
    2009-11-20

    (186 days)

    Product Code
    NST
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    NST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum. The AChRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.
    Device Description
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    K Number
    K080523
    Device Name
    KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2008-06-17

    (112 days)

    Product Code
    NST
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    NST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).
    Device Description
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    K Number
    K051144
    Device Name
    ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
    Manufacturer
    IBL-HAMBURG GMBH
    Date Cleared
    2005-11-18

    (198 days)

    Product Code
    NST
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    NST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitrodiagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma. The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
    Device Description
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    K Number
    K042248
    Device Name
    KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2004-12-17

    (120 days)

    Product Code
    NST
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    NST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum. The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.
    Device Description
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