BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IML 2000

    Reg #: 2247117 · FEI: 1000122204 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    2247117
    FEI Number
    1000122204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    62 FLANDERS-BARTLEY RD.
    City
    FLANDERS
    State
    NJ
    ZIP
    07836
    Country
    US

    Regulatory Submissions

    PMA Number
    P010053

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) LOM

    Proprietary Names

    IML 2000 IML 1000 IMMULITE Anti-Hepititis B Core IMMULITE 2000 Anti-HBc IgM IMMULITE 2000 XPi System (Automated Immunoassay Analyzer)

    Establishment Types

    Manufacture Medical Device