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510(k) Data Aggregation

    K Number
    K103037
    Device Name
    IND URINARY TRACT INFECTION (UTI) TEST STRIPS
    Manufacturer
    IND DIAGNOSTIC, INC.
    Date Cleared
    2012-04-17

    (551 days)

    Product Code
    NGJ, LJX
    Regulation Number
    862.1510
    Why did this record match?
    Product Code :

    NGJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IND Urinary Tract Infection (UTI) Test Strips are intended for qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection in persons with signs and symptoms of urinary tract infection. Testing of urine is performed by urinating into a sample cup and briefly dipping the test strip into it. This test is intended for over-the-counter home use only.
    Device Description
    Not Found
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