BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Multiconstituent Calibrator

    Reg #: 3010939897 · FEI: 3010939897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Microgenics Corporation
    Registration Number
    3010939897
    FEI Number
    3010939897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    46500 Kato Road
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    Multiconstituent Calibrator Alinity c Carbon Dioxide Calibrator Bilirubin Calibrator Alinity c Urine/CSF Protein Calibrator Kit Alinity c Iron Calibrator Kit Alinity i Anti-TPO Controls Carbon Dioxide Calibrator

    Establishment Types

    Manufacture Device in the United States for Export Only