BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    BD MAX PCR Cartridge

    Reg #: 3007420875 · FEI: 3007420875 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GeneOhm Sciences Canada, ULC.
    Registration Number
    3007420875
    FEI Number
    3007420875
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2555 Boul. du Parc-Technologique
    City
    Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K111860

    Owner / Operator

    Firm Name
    Becton Dickinson and Company
    Operator Number
    9922032
    Address
    One Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    US Agent

    Business Name
    BECTON DICKINSON AND COMPANY
    Contact Name
    Jeffrey Zinza
    Address
    7 Loveton Circle
    City
    Sparks
    State
    MD
    ZIP
    21152
    Country
    US
    Email
    [email protected]
    Phone
    858 2093953

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR

    Proprietary Names

    BD MAX PCR Cartridge BD MAX GBS Assay on BD MAX System BD MAX PCR Cartridges

    Establishment Types

    Manufacture Medical Device