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    K Number
    K030826
    Device Name
    PRECISET DAT AMPHETAMINE
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2003-04-03

    (20 days)

    Product Code
    DIJ
    Regulation Number
    862.3550
    Why did this record match?
    Product Code :

    DIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
    Device Description
    The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.
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