BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Mycoplasma genitalium Macrolide Resistance IVT A2059G Control

    Reg #: 3010534606 · FEI: 3010534606 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DIAGENODE s.a.
    Registration Number
    3010534606
    FEI Number
    3010534606
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue du Bois Saint Jean 3
    City
    Seraing Liege
    Country
    BE

    Owner / Operator

    Firm Name
    Diagenode s.a.
    Operator Number
    10079757
    Address
    Rue du Bois Saint Jean 3
    City
    Seraing
    State
    Liege
    Postal Code
    4102
    Country
    BE
    Correspondent
    Geraldine Poncin

    US Agent

    Business Name
    Hologic Inc.
    Contact Name
    Jeffrey Hergesheimer
    Address
    10210 Genetic center Dr.
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 4108536

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Mycoplasma genitalium Macrolide Resistance IVT A2059G Control Mycoplasma genitalium Macrolide Resistance IVT A2058T Control Mycoplasma genitalium Macrolide Resistance IVT A2058G Control Mycoplasma genitalium Macrolide Resistance IVT A2059C Control Mycoplasma genitalium IVT WT Control Mycoplasma genitalium Macrolide Resistance IVT A2058C Control

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device