BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADVIA Centaur Intact Parathyroid Hormone (iPTH)

    Reg #: 1219913 · FEI: 1219913 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    1219913
    FEI Number
    1219913
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    333 Coney Street
    City
    E Walpole
    State
    MA
    ZIP
    02032
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163658

    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
    Radioimmunoassay, Parathyroid Hormone CEW

    Proprietary Names

    ADVIA Centaur Intact Parathyroid Hormone (iPTH) ADVIA Centaur Intact Parathyroid Hormone (PTH) Quality Control ADVIA Centaur Intact Parathyroid Hormone (PTH) ADVIA Centaur Intact Parathyroid Hormone (PTH) Master Curve Atellica IM Intact Parathyroid Hormone Quality Control (PTH QC) Atellica IM Intact Parathyroid Hormone Master Curve Material (PTH MCM) Atellica IM Intact Parathyroid Hormone (PTH)

    Establishment Types

    Manufacture Medical Device