BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Rapid Response H. pylori Rapid Test Device (Whole Blood)

    Reg #: 3003917514 · FEI: 3003917514 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    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
    K024350

    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
    Helicobacter Pylori LYR

    Proprietary Names

    Rapid Response H. pylori Rapid Test Device (Whole Blood) Rapid Response H. pylori Rapid Test Device (Serum/Plasma)

    Establishment Types

    Foreign Private Label Distributor Repack or Relabel Medical Device