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510(k) Data Aggregation

    K Number
    K981084
    Device Name
    URISCREEN
    Date Cleared
    1998-10-07

    (196 days)

    Product Code
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIATECH DIAGNOSTICS,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Uriscreen is a non-quantitative rapid screen for the detection of Urinary Tract Infection. Uriscreen detects both bacteria and/or white blood cells, common indicators of Urinary Tract Infection. Uriscreen is a non-quantitative rapid screen, which detects catalase. Urinary catalase may be associated with White Blood Cells, bacteria and other cells, some of which may be indicators of urinary tract infection. Only Adults should use the test.
    Device Description
    Uriscreen - Uriscreen is a rapid screen for the detection of Urinary Tract Infection. Uriscreen detects Catalase activity. Most organisms that commonly cause Urinary Tract Infection are Catalase positive. Additionally, Catalase activity is an indicator of white blood cells in urine. White blood cells are a common indicator of Urinary Tract Infection. Uriscreen tubes contain a reagent powder, which enables Catalase detection. Urine is added to the tube to the line indicated, a few drops of hydrogen peroxide solution are added. Production of foam indicates Catalase activity. Catalase activity is indicative of bacteria and/or white blood cells in the urine. Most bacteria that commonly cause urinary tract infection are Catalase positive. The presence of bacteria and/or white blood cells in the urine are clearly indicative of Urinary Tract Infection.
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