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510(k) Data Aggregation

    K Number
    K972618
    Device Name
    QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
    Manufacturer
    PHAMATECH
    Date Cleared
    1997-08-08

    (28 days)

    Product Code
    DMN
    Regulation Number
    862.3250
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    Product Code :

    DMN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of cocaine and the cocaine metabolite benzoylecgonine, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
    Device Description
    A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of cocaine and the cocaine metabolite benzoylecgonine, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose. The QuickScreen TM One Step Cocaine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (Cocaine) test kits, to qualitatively measure for the presence of Cocaine by visual color sandwich one step immunoassay technology.
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