BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Rapid Response Multi-Drug One Step Cup (Urine)

    Reg #: 3003917514 · FEI: 3003917514 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    BTNX Inc.
    Registration Number
    3003917514
    FEI Number
    3003917514
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    722 Rosebank Road
    City
    Pickering Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K180349

    Owner / Operator

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

    US Agent

    Business Name
    Phil Triolo and Associates LC
    Contact Name
    Phil Triolo
    Address
    86 Skycrest Lane
    City
    Emigration Canyon
    State
    UT
    ZIP
    84108
    Country
    US
    Email
    [email protected]
    Phone
    801 6999846

    Products

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

    Proprietary Names

    Rapid Response Multi-Drug One Step Cup (Urine) Rapid Response Multi-Drug Test Panel (Urine) Rapid Response One Step DOA Cup MOR 300 (Urine) Rapid Response One Step DOA Test Cup (Urine) Rapid Response Single/Multi DOA Panel MOR 300 (Urine) Rapid Response One Step DOA Cup MOR 2000 (Urine) Rapid Response Multi-Drug Test Cup Rapid Response Single/Multi DOA Panel MOR 2000 (Urine)

    Establishment Types

    Foreign Private Label Distributor Repack or Relabel Medical Device