BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BD CD19(4G7) PE (AKA Anti-Leu-12 B Cell Reagent)

    Reg #: 3008352382 · FEI: 3008352382 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Becton Dickinson Caribe, LTD
    Registration Number
    3008352382
    FEI Number
    3008352382
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vicks Drive, Lot 1 Corner Road 735
    City
    Cayey
    State
    PR
    ZIP
    00736
    Country
    US

    Regulatory Submissions

    510(k) Number
    K851639

    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

    Products

    Device Name Product Code
    Assay, B Lymphocyte Marker LJD

    Proprietary Names

    BD CD19(4G7) PE (AKA Anti-Leu-12 B Cell Reagent)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)