LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972577
    Device Name
    QUICK SCREEN ONE STEP AMPHETAMINE TEST
    Manufacturer
    PHAMATECH
    Date Cleared
    1997-08-20

    (41 days)

    Product Code
    DIT
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    DIT

    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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
    Device Description
    The QuickScreenTM One Step Amphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine by visual color sandwich one step immunoassay technology.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1