BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hologic, Inc.

    Reg #: 1221855 · FEI: 1221855 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Hologic, Inc.
    Registration Number
    1221855
    FEI Number
    1221855
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4 Navigator Rd
    City
    LONDONDERRY
    State
    NH
    ZIP
    03053
    Country
    US

    Regulatory Submissions

    PMA Number
    P950039

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Preservative, Cytological LEA
    Filters, Cell Collection, Tissue Processing KET
    Stain, Papanicolau HZJ
    Reader, Cervical Cytology Slide, Automated MNM
    Processor, Cervical Cytology Slide, Automated MKQ

    Proprietary Names

    PreservCyt and CytoLyt ThinPrep filters ThinPrep Imaging System Stain ThinPrep 5000 Processor ThinPrep Gynecological Slides ThinPrep Gynecological Filters ThinPrep 2000 Slide Processor ThinPrep Gynecological Preservative (PreservCyt) ThinPrep® CERV(TM) PreservCyt® Solution ThinPrep® CERV(TM) Gynecological Filters ThinPrep Genesis Processor

    Establishment Types

    Manufacture Medical Device