BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Access Hybritech PSA Calibrators (P/N: 37205 MN MFG)

    Reg #: 9680746 · FEI: 1000206808 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    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
    P850048

    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
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF

    Proprietary Names

    Access Hybritech PSA Calibrators (P/N: 37205 MN MFG) Access Hybritech PSA (P/N: 37200 MN and IE MFG) Access Hybritech PSA Sample Diluent (P/N: 37206 MN MFG) Access Hybritech PSA (P/N: C22845 MN MFG)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)