BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Panther Fusion GBS Assay

    Reg #: 2024800 · FEI: 2024800 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hologic, Inc.
    Registration Number
    2024800
    FEI Number
    2024800
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10210 Genetic Center Dr
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    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
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR

    Proprietary Names

    Panther Fusion GBS Assay Panther Fusion Extraction Reagent-X 960 Tests Panther Fusion GBS Assay Controls Panther Fusion GBS Assay Cartridges 96 Tests Panther Fusion Internal Control-X 960 Tests

    Establishment Types

    Manufacture Medical Device