BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CELLSOLUTIONS LLC

    Reg #: 3009034535 · FEI: 3009034535 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    10

    Registration Details

    Registration Name
    CELLSOLUTIONS LLC
    Registration Number
    3009034535
    FEI Number
    3009034535
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1100 Revolution Mill Dr
    City
    Greensboro
    State
    NC
    ZIP
    27405
    Country
    US

    Regulatory Submissions

    510(k) Number
    K930955

    Owner / Operator

    Firm Name
    CellSolutions LLC
    Operator Number
    10045470
    Address
    1100 Revolution Mill Drive
    City
    Greensboro
    State
    NC
    Postal Code
    27405
    Country
    US
    Correspondent
    Joel C Dry

    Products

    Device Name Product Code
    Preservative, Cytological LEA
    Station, Pipetting And Diluting, For Clinical Use JQW
    Processor, Tissue, Automated IEO
    Slides, Microscope KEW
    Cytology Kit OKY
    Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System NVV
    Spatula, Cervical, Cytological HHT
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    General Purpose Reagent PPM
    Filters, Cell Collection, Tissue Processing KET

    Proprietary Names

    BTA C-101A General Cytology Preservative CS30 F50 CellSolutions Slides BestCyte Image Display and Training System Cervex-Brush BestPrep General Cytology Preservative Horizon 24 Flex 24 Place Centrifuge CellSolutions Red Lytic General Cytology Preservative Rovers Cervex-Brush Combi PapCone CellSolutions Small Filter Kit CellSolutions Filter Kit

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility