BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Uracil-N-Glycosylase (UNG) for use with Abbott RealTime MTB CE (08N15-067)

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT MOLECULAR, INC.
    Registration Number
    3005248192
    FEI Number
    3005248192
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 EAST TOUHY AVENUE
    City
    Des Plaines
    State
    IL
    ZIP
    60018
    Country
    US

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex MWA

    Proprietary Names

    Uracil-N-Glycosylase (UNG) for use with Abbott RealTime MTB CE (08N15-067) Abbott RealTime MTB Assay CD-ROM (08N15-001, 08N15-002) RealTime MTB Control Kit (08N15-080) RealTime MTB Amplification Reagent Kit (08N15-090) RealTime MTB RIF/INH Resistance Amplification Reagent Kit (08N28-090) RealTime MTB RIF/INH Resistance Including Uracil-N-Glycosylase (UNG (08N28-067) RealTime MTB RIF/INH Resistance ROW System Combined Application CD ROM (08N28-001) RealTime MTB RIF/INH Resistance Control Kit (08N28-080)

    Establishment Types

    Manufacture Device in the United States for Export Only