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510(k) Data Aggregation

    K Number
    K961375
    Device Name
    DIA SCREEN 10 WAY REAGENT STRIPS
    Manufacturer
    GENESIS LABS, INC.
    Date Cleared
    1996-06-18

    (70 days)

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

    GENESIS LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semiquantitative urinalysis. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to test semiguantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, billirubin, and urobilinogen by visual comparison with a color chart.
    Device Description
    DIA SCREEN® Reagent Strips are plastic strips to which are affixed reagent areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen, The reagent test areas on the DIA SCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
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