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510(k) Data Aggregation

    K Number
    K062626
    Device Name
    CORTISOL ELISA
    Manufacturer
    IBL-HAMBURG GMBH
    Date Cleared
    2006-12-20

    (106 days)

    Product Code
    CGR
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBL-HAMBURG GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Cortisol enzym linked immunosorbent assay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva. The Cortisol ELISA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.
    Device Description
    Solid phase enzyme-linked immunosorbent assay (ELISA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
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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?
    Applicant Name (Manufacturer) :

    IBL-HAMBURG GMBH

    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
    Not Found
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