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510(k) Data Aggregation

    K Number
    K040703
    Device Name
    URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
    Manufacturer
    DIRUI INDUSTRIAL CO., LTD.
    Date Cleared
    2004-08-26

    (162 days)

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

    DIRUI INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening in the following areas: - Kidney function - Urinary tract infections - Carbohydrate metabolism (e.g. diabetes mellitus) - Liver function - Acid-base balance - Urine concentration Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
    Device Description
    URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.
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