BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dimension TPSA Flex

    Reg #: 2517506 · FEI: 2517506 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Registration Number
    2517506
    FEI Number
    2517506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 GBC DR, PO Box 6101
    City
    NEWARK
    State
    DE
    ZIP
    19714
    Country
    US

    Regulatory Submissions

    PMA Number
    P000021

    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

    Dimension TPSA Flex Vista TPSA Flex

    Establishment Types

    Manufacture Medical Device