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510(k) Data Aggregation

    K Number
    K083724
    Device Name
    WIENER LAB. URINE STRIP 10 AND 11
    Manufacturer
    WIENER LABORATORIOS S.A.I.C.
    Date Cleared
    2009-09-02

    (261 days)

    Product Code
    JIO, CDM, CEN, JIL, JIN, JIR, JJB, JMA, JMT, JRE, LJX
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    WIENER LABORATORIOS S.A.I.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urine strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations. Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine. Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.
    Device Description
    Wiener lab. Urine Strip are plastic strips to which glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leucocytes and ascorbic acid reagents pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The instructions for use must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
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