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    K Number
    K013643
    Device Name
    AUSAM TOTAL ALBUMIN ASSAY
    Manufacturer
    AUSAM BIOTECTHNOLOGIES INC
    Date Cleared
    2003-08-14

    (647 days)

    Product Code
    JIQ
    Regulation Number
    862.1645
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSAM BIOTECTHNOLOGIES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.
    Device Description
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