BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Multi-4 CO-Oximeter Control - Level 3

    Reg #: 3037000637 · FEI: 3037000637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO. - Devens
    Registration Number
    3037000637
    FEI Number
    3037000637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11 Grant Road
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Owner / Operator

    Firm Name
    Instrumentation Laboratory Co.
    Operator Number
    1217183
    Address
    180 Hartwell Road, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Carol - Marble

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    Multi-4 CO-Oximeter Control - Level 3 Avox-4 Co-Oximeter Control - L2 IL PVP GEM ChemSTAT CVP 3 GEM ChemSTAT CVP 4 Multi-4 CO-Oximeter Control, Multi GEM ChemSTAT CVP 1 GEM ChemSTAT CVP 2 Avox-4 Co-Oximeter Control - L3 Multi-4 CO-Oximeter Control - Level 2 Avox-4 Co-Oximeter Control - L1 Multi-4 CO-Oximeter Control - Level 1 ChemSTAT System Evaluator 2 GEM ChemSTAT PVP 1-5 Avox-4 Co-Oximeter Control ChemSTAT System Evaluator 1 ChemSTAT System Evaluator 3 GEM System Evaluator 2 GEM System Evaluator 1 GEM CVP 5 tBili GEM System Evaluator 3

    Establishment Types

    Repack or Relabel Medical Device