BEUDAMED
    FDA Registration Active 🇫🇷 France

    Access SHBG (P/N: A48617 MN MFG)

    Reg #: 8023018 · FEI: 3002807272 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Immunotech SAS, a Beckman Coulter company
    Registration Number
    8023018
    FEI Number
    3002807272
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    130 AVENUE DE LATTRE DE TASSIGNY, BP 177
    City
    MARSEILLE, CEDEX 9 Bouches-du-Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K083867

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    US Agent

    Business Name
    BECKMAN COULTER, INC.
    Contact Name
    David Davis
    Address
    250 S. Kraemer Blvd.
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    469 2368180

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ

    Proprietary Names

    Access SHBG (P/N: A48617 MN MFG) Access SHBG Calibrators (P/N: A48618 FR MFG) Access SHBG QC (P/N: A48619 FR MFG) Access SHBG Calibrators Access SHBG QC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)