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    K Number
    K020226
    Device Name
    XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
    Manufacturer
    HELLEN PROFESSIONAL SERVICES
    Date Cleared
    2002-08-22

    (212 days)

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

    HELLEN PROFESSIONAL SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test is Intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. Early detection and treatment of trichomonas-related diseases (vaginitis, trichomoniasis) is useful in the prevention and reduction of disease and disease symptomology.
    Device Description
    Not Found
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    K Number
    K981536
    Device Name
    QUANTECH MYOGLOBIN ASSAY
    Manufacturer
    HELLEN PROFESSIONAL SERVICES
    Date Cleared
    1998-06-29

    (61 days)

    Product Code
    MVE, DRD
    Regulation Number
    866.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    HELLEN PROFESSIONAL SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantech Myoglobin Assay is intended to be used as an aid in diagnosing myocardial infarction in patients exhibiting chest pain. It is intended to be used in conjunction with EKG, and physician examination, as well as possibly other biochemical blood tests to rule in or out non-cardiac damaging origin of the chest pain.
    Device Description
    The Quantech Myoglobin Assay is based on the principle of two site, or sandwich immunoassay in combination with SPR surface mass measurement. Each test module contains a solid phase anti-myoglobin monoclonal antibody immobilized onto a gold surface. An anti-myoglobin enzyme conjugate solution and wash solution are used to enhance the specific detection of myoglobin. The Quantech assay utilizes myoglobin-specific antibody to capture the myoglobin in the sample. This is followed by a quantitation of the surface mass increase using surface plasmon resonance (SPR), to measure the myoglobin in serum.
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