BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GC-100NE Cellsolutions Manual GluCyte Cell Adherent 100mL

    Reg #: 3003593973 · FEI: 3003593973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Infrared Laboratory Systems dba SYNERMED
    Registration Number
    3003593973
    FEI Number
    3003593973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17408 Tiller Ct Ste 1900
    City
    WESTFIELD
    State
    IN
    ZIP
    46074
    Country
    US

    Owner / Operator

    Firm Name
    Infrared Laboratory Systems, LLC
    Operator Number
    10038715
    Address
    17408 Tiller Court Suite 1900
    City
    Westfield
    State
    IN
    Postal Code
    46074
    Country
    US
    Correspondent
    Craig L Denney

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    GC-100NE Cellsolutions Manual GluCyte Cell Adherent 100mL SS-250 Slideslick Glass Slide Cleaner GCI-100NE CellSolutions Manual GluCyte Cell Adherent 100mL GCKI-100-M CellSolutions Manual GluCyte Cytology Preparation Kit 100 tests and vials GCK-500-M CellSolutions Manual GluCyte Cytology Preparation Kit 500 tests GC-100E Cellsolutions GluCyte Cell Adherent 100mL GCK-500-A CellSolutions Automated GluCyte Cytology Preparation Kit 500 tests GCI-25NE Cellsolutions Manual GluCyte Cell Sdherent 25mL GCI-100ANE CellSolutions Automated GluCyte Cell Adherent 100mL GC1000E CellSolutions gluCyte Cell Adherent 1 Liter GCK-100-M CellSolutions Manual GluCyte Cytology Preparation Kit 100 tests and vials GC-25NE CellSolutions Manual GluCyte Cell Adherent 25mL GCKI-500-A CellSolutions Automated GluCyte Cytology Preparation Kit 500 tests DR-101G CellSolutions Density Reagent 4x1 Liter GCI-100E CellSolutions GluCyte Cell Adherent 100mL DR-101-L Cellsolutions Density Reagent 1 Liter GCKI-500-M Cellsolutions Manual GluCyte Cytology Preparation Kit 500 tests

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)