BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    IMMULITE OM-MA

    Reg #: 3002806944 · FEI: 3002806944 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
    Registration Number
    3002806944
    FEI Number
    3002806944
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GLYN RHONWY
    City
    LLANBERIS Wales
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K981297

    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, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK

    Proprietary Names

    IMMULITE OM-MA IMMULITE IML 2500 OM-MA IMMULITE/IMMULITE 1000 OM-MA Sample Diluent

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device