BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BD Simultest Leucogate

    Reg #: 3008352382 · FEI: 3008352382 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    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
    K913192

    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
    Counter, Differential Cell GKZ

    Proprietary Names

    BD Simultest Leucogate BD Simultest CD3/CD19 BD Simultest IgG1/IgG2 BD Simultest CD3/CD8 BD Simultest IMK-Lymphocyte BD Simultest CD3/CD4 BD Simultest CD3/CD16+56 BD SimulSET Software

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)