BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Access Hybritech free PSA (P/N: 37210 MN and IE MFG)

    Reg #: 9680746 · FEI: 1000206808 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beckman Coulter Ireland Inc
    Registration Number
    9680746
    FEI Number
    1000206808
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LISMEEHAN
    City
    O CALLAGHANS MILLS Clare
    Country
    IE

    Regulatory Submissions

    PMA Number
    P970038

    Owner / Operator

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

    Products

    Device Name Product Code
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions MTG

    Proprietary Names

    Access Hybritech free PSA (P/N: 37210 MN and IE MFG) Access Hybritech Free PSA Calibrators (P/N: 37215 MN MFG) Access Hybritech free PSA (P/N: C22846 MN MFG)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)