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510(k) Data Aggregation

    K Number
    K231045
    Device Name
    Healgen URS Test Strips
    Manufacturer
    Healgen Scientific LLC
    Date Cleared
    2023-06-16

    (65 days)

    Product Code
    LJX, JMT
    Regulation Number
    864.7675
    Why did this record match?
    Product Code :

    LJX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Healgen URS Test Strips are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.
    Device Description
    Healgen URS Test Strips are in vitro diagnostic test devices for qualitative detection of leukocyte and nitrite in urine. The device is composed of two color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart.
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    K Number
    K063295
    Device Name
    ACON UTI URINARY TRACT INFECTION TEST STRIPS
    Manufacturer
    ACON LABORATORIES, INC.
    Date Cleared
    2007-10-12

    (345 days)

    Product Code
    LJX, JMT
    Regulation Number
    864.7675
    Why did this record match?
    Product Code :

    LJX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACON UTI Urinary Tract Infection Test Strips is for the qualitative detection of Leukocyte and Nitrite in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
    Device Description
    The ACON UTI Urinary Tract Infection Test Strips for Leukocytes and Nitrite are urine test strips of which Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for over-the-counter home use with human urine.
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    K Number
    K000578
    Device Name
    SERIM LEUKOCYTE ESTERASE TEST STRIPS
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2000-05-05

    (73 days)

    Product Code
    LJX
    Regulation Number
    864.7675
    Why did this record match?
    Product Code :

    LJX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981555
    Device Name
    DIASCREEN REAGENT STRIPS
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    1998-06-01

    (31 days)

    Product Code
    LJX
    Regulation Number
    864.7675
    Why did this record match?
    Product Code :

    LJX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
    Device Description
    DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test 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, leukocytes, nitrite, pH, bilirubin, and urobilinogen. The reagent test areas on the DIASCREEN® 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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    K Number
    K971976
    Device Name
    DIASCREEN REAGENT STRIPS
    Manufacturer
    DIA-SCREEN CORP.
    Date Cleared
    1997-06-17

    (19 days)

    Product Code
    LJX, JNA, KQO
    Regulation Number
    864.7675
    Why did this record match?
    Product Code :

    LJX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart. The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format. The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
    Device Description
    DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test 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, leukocytes, nitrite, pH, bilirubin, and urobilinogen. The reagent test areas on the DIASCREEN® 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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