BEUDAMED
    FDA Registration Active 🇺🇸 United States

    digene® HC2 CT/GC DNA Test, Version 2

    Reg #: 1122376 · FEI: 3003572099 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QIAGEN
    Registration Number
    1122376
    FEI Number
    3003572099
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    19300 Germantown Rd
    City
    Germantown
    State
    MD
    ZIP
    20874
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981485

    Owner / Operator

    Firm Name
    QIAGEN Sciences LLC
    Operator Number
    9002668
    Address
    19300 Germantown Road, --
    City
    Germantown
    State
    MD
    Postal Code
    20874
    Country
    US

    Products

    Device Name Product Code
    Dna-Reagents, Neisseria LSL

    Proprietary Names

    digene® HC2 CT/GC DNA Test, Version 2 digene® HC2 GC-ID DNA Test, Version 2

    Establishment Types

    Manufacture Medical Device