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510(k) Data Aggregation

    K Number
    K980836
    Device Name
    GENIE CUP INTEGRATED SCREENING DEVICE
    Manufacturer
    APPLIED TECHNOLOGY VENTURES, L.L.C.
    Date Cleared
    1998-06-29

    (117 days)

    Product Code
    LDJ, DIO, DJG, DKZ, LCM
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED TECHNOLOGY VENTURES, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of the following drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations.
    Device Description
    Not Found
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    K Number
    K973726
    Device Name
    FINGERPRINT DRUG SCREENING DEVICE
    Manufacturer
    APPLIED TECHNOLOGY VENTURES, L.L.C.
    Date Cleared
    1997-11-06

    (37 days)

    Product Code
    DKZ, DIO, DJG, LCM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED TECHNOLOGY VENTURES, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FINGERPRINT Drug Screening Device™ is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the National Institute on Drug Abuse (NIDA) specified cutoff concentrations. AMP amphetamines 1000 ng/ml COC cocaine 300 ng/ml MOR opiates 300 ng/ml PCP phencyclidine 25 ng/ml THC cannabinoids 50 ng/ml FINGERPRINT Drug Screening Device™ test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmed analytical result. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
    Device Description
    Not Found
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