BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lochness Medical

    Reg #: 3008741972 · FEI: 3008741972 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    13

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    Registration Details

    Registration Name
    Lochness Medical
    Registration Number
    3008741972
    FEI Number
    3008741972
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2775 Broadway
    City
    Buffalo
    State
    NY
    ZIP
    14227
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243996

    Owner / Operator

    Firm Name
    BTNX Inc.
    Operator Number
    9058575
    Address
    722 Rosebank Road
    City
    PICKERING
    State
    Ontario
    Postal Code
    L1W 4B2
    Country
    CA

    Products

    Device Name Product Code
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Barbiturate, Over The Counter PTH
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Benzodiazepine, Over The Counter NFV
    Test, Methadone, Over The Counter PTG
    Test, Methamphetamine, Over The Counter NGG
    Test, Cannabinoid, Over The Counter NFW
    Test, Opiates, Over The Counter NGL
    Test, Propoxyphene, Over The Counter QBF
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Morphine, Over The Counter NGI

    Proprietary Names

    Rapid Response Drug Test Panel Rapid Response Home Drug Test Cup Rapid Response Home Drug Test Panel Rapid Response Drug Test Cup Rapid Response Home Drug Monitoring Cup Rapid Response Drug Monitoring Cup Rapid Response Drug Monitoring Panel Rapid Response Home Drug Monitoring Panel Rapid Response Multi-Drug Screen Cup

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198