BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Aptima Mycoplasma genitalium Assay

    Reg #: 3011215818 · FEI: 3011215818 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HOLOGIC, LTD.
    Registration Number
    3011215818
    FEI Number
    3011215818
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oaks Business Park, Crewe Road
    City
    Wythenshawe Manchester
    Country
    GB

    Regulatory Submissions

    510(k) Number
    DEN180047

    Owner / Operator

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

    US Agent

    Business Name
    Hologic Inc.
    Contact Name
    Jeff Zinza
    Address
    10210 Genetic center Dr.
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 4108389

    Products

    Device Name Product Code
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP

    Proprietary Names

    Aptima Mycoplasma genitalium Assay Aptima Mycoplasma genitalium Calibrators Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)