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    K Number
    K091849
    Device Name
    IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
    Manufacturer
    IMMUNODIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    2010-06-25

    (368 days)

    Product Code
    MRG, JJE, JJX
    Regulation Number
    862.1825
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNODIAGNOSTIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use. The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population. The kit is for in vitro diagnostic use only. The IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin D Assay.
    Device Description
    The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use. The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser.
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