BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01)

    Reg #: 3002809144 · FEI: 3002809144 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    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
    P110029

    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
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) LOM

    Proprietary Names

    ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01) ARCHITECT HBsAg Qualitative Controls (LN 4P53-10) Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (LN 08P1141) Alinity i HBsAg Qualitative II Controls (LN 08P1012) Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (LN 08P1121) Alinity i HBsAg Qualitative II Reagent Kit (LN 08P1021, 08P1031) Alinity i HBsAg Qualitative II Calibrators (LN 08P1002) ARCHITECT HBsAg Qualitative Reagent Kit (LN 4P53-25, 4P53-35) ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit (LN 4P54-25) ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent (LN 4P54-40)

    Establishment Types

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