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    K Number
    K991927
    Device Name
    MEDI-TEST COMBI 11
    Manufacturer
    MACHEREY-NAGEL-DUREN
    Date Cleared
    1999-09-17

    (101 days)

    Product Code
    JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MACHEREY-NAGEL-DUREN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Test Combi 11 Reagent Strip for Urinalysis is a dip-and-read test strip. The product is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes, metabolic, abnormalities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract. The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen by visual comparison with a color chart for each concentration range.
    Device Description
    The Medi-Test Combi 11 Reagent Strip for urinalysis is a dip-and-read test strip. The Medi-Test Combi 11 provides reagent areas on the strip for testing urine physiological parameters. The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, ascorbic acid, protein, blood, nitrite, pH, ketones, bilirubin and urobilinogen by visual comparison with a color chart for each concentration range.
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