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    K Number
    K180607
    Device Name
    Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
    Manufacturer
    KRONUS, Inc.
    Date Cleared
    2018-11-23

    (261 days)

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

    PCG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
    Device Description
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    K Number
    K121046
    Device Name
    STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2012-12-20

    (258 days)

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

    PCG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
    Device Description
    Not Found
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