BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    PAXgene Blood RNA System

    Reg #: 3013055489 · FEI: 3013055489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BD European Distribution Center
    Registration Number
    3013055489
    FEI Number
    3013055489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Laagstraat 57
    City
    Temse Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    DEN050003

    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
    David Pieratos
    Address
    1 Becton Drive, MC980
    City
    Franklin Lakes
    State
    NJ
    ZIP
    07417
    Country
    US
    Email
    [email protected]
    Phone
    201 8474548

    Products

    Device Name Product Code
    System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test NTW

    Proprietary Names

    PAXgene Blood RNA System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device