BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    IMMULITE 2000 PSA

    Reg #: 3002806944 · FEI: 3002806944 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    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

    PMA Number
    P930027

    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
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ

    Proprietary Names

    IMMULITE 2000 PSA IML 1000 IMMULITE 2000 Third Generation PSA Total Prostate Specific Antigen (PSA) IMMULITE PSA IMMULITE 3rd Generation PSA IMMULITE 3rd Generation PSA Control Module

    Establishment Types

    Manufacture Medical Device