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    K Number
    K971458
    Device Name
    ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
    Manufacturer
    DIAGNOSTIC SPECIALTIES
    Date Cleared
    1997-09-02

    (133 days)

    Product Code
    JIQ
    Regulation Number
    862.1645
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    Applicant Name (Manufacturer) :

    DIAGNOSTIC SPECIALTIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine.
    Device Description
    EnZIP IMMUNOTURBIDIMETRIC URINARY MICROALBUMIN KIT
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