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510(k) Data Aggregation

    K Number
    K020595
    Device Name
    XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
    Manufacturer
    XENOTOPE DIAGNOSTICS, INC.
    Date Cleared
    2003-02-20

    (363 days)

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

    XENOTOPE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.
    Device Description
    Not Found
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