BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CMV IgM

    Reg #: 2432235 · FEI: 2432235 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    2432235
    FEI Number
    2432235
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    511 Benedict Ave
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100433

    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Antibody Igm,If, Cytomegalovirus Virus LKQ

    Proprietary Names

    CMV IgM IMMULITE 2000 CMV IgM ADVIA Centaur CMV IgM (CMV IgM) ADVIA Centaur CMV IgM Quality Control (CMV IgM QC) Atellica IM CMV IgM Quality Control (CMV IgM QC) Atellica IM CMV IgM (CMV IgM)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility