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    K Number
    K123763
    Device Name
    IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
    Manufacturer
    IMMUNODIAGNOSTIC SYSTEMS LTD.
    Date Cleared
    2013-12-24

    (382 days)

    Product Code
    CIB
    Regulation Number
    862.1085
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension. The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.
    Device Description
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    K Number
    K062120
    Device Name
    CISBIO RENIN RIA TEST
    Manufacturer
    CIS BIO INTERNATIONAL
    Date Cleared
    2007-03-30

    (248 days)

    Product Code
    CIB
    Regulation Number
    862.1085
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    Matched: '862.1085'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A radioimmunoassay for the quantitative in vitro diagnostic measurement of the level of renin in plasma. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
    Device Description
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