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510(k) Data Aggregation

    K Number
    K024339
    Device Name
    COZART EIA OPIATES ORAL FLUID KIT
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2003-04-07

    (101 days)

    Product Code
    DIG
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cozart EIA Opiates Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for Opiates in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.
    Device Description
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