BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35)

    Reg #: 3008344661 · FEI: 3008344661 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    ABBOTT IRELAND
    Registration Number
    3008344661
    FEI Number
    3008344661
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    DIAGNOSTICS DIVISION, FINISKLIN BUSINESS PARK
    City
    SLIGO
    Country
    IE

    Regulatory Submissions

    PMA Number
    P910007

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    ABBOTT LABORATORIES
    Contact Name
    Sara Qadri
    Address
    675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US
    Email
    [email protected]
    Phone
    224 6680142

    Products

    Device Name Product Code
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Calibrator, Primary JIS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35) ARCHITECT Total PSA Controls (LN 6C06-10) ARCHITECT Total PSA Calibrators (LN 6C06-01) Alinity i Total PSA Reagent Kit (LN 07P9221, 07P9231) Alinity i Total PSA Calibrators (LN 07P9201) Alinity i Total PSA Controls (LN 07P9210)

    Establishment Types

    Manufacture Medical Device