BEUDAMED
    FDA Registration Active 🇩🇪 Germany

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

    Reg #: 3002809144 · FEI: 3002809144 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    ABBOTT GmbH
    Registration Number
    3002809144
    FEI Number
    3002809144
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Planck-Ring 2
    City
    Wiesbaden Hesse
    Country
    DE

    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

    Export Device to the United States But Perform No Other Operation on Device