BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CEDIA Negative Calibrator

    Reg #: 3010939897 · FEI: 3010939897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    Establishment Types
    2
    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
    Calibrators, Drug Mixture DKB

    Proprietary Names

    CEDIA Negative Calibrator CEDIA Multi-Drug Calibrators CEDIA Multi-Drug OFT Calibrators Siemens ADVIA Chemistry Negative Drug Urine Calibrator Siemens ADVIA Chemistry Serum Toxicology Calibrators DRI Multi-Drug Urine Calibrators CEDIA AntibioticTDM Multi-Calibrator Alinity c DOA MC Negative Calibrator Kit Alinity c DOA MC Qual Low Calibrator 1 Kit Alinity c TDM Multiconstituent Calibrator Kit CEDIA Antibiotic TDM Multi-Cal Alinity c Tox Semiquant Calibrators Siemens Dimension Vista Drug 2 Calibrator Siemens Dimension Drug Cal II DRI Negative Urine Calibrator DRI Drugs of Abuse Low Calibrator Alinity c DOA MC Semiquant Calibrator Kit Siemens ADVIA Chemistry DRUG Calibrator II Alinity c Benzodiazepines Semiquant Calibrator Kit DRI Serum Tox Cals Siemens Atellica CH Drug II Cal Alinity c DOA MC Qual Calibrator 2 Kit DRI Drugs of Abuse High Calibrator Alinity c Tox Qual Calibrators Alinity c Benzodiazepines Qual Calibrator Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device