BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott RealTime KRAS m2000 RT Application CD ROM (08N04-001)

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    Somatic Gene Mutation Detection System OWD

    Proprietary Names

    Abbott RealTime KRAS m2000 RT Application CD ROM (08N04-001) Abbott RealTime BRAF V600 E/K/D Mutations Control Kit (List No. 07N60-80) Abbott RealTime BRAF V600 E/K/D Mutations Amplification Reagent Kit (List No. 07N60-90) TargetPrep DNA FFPE Sample Preparation Kit II (List No. 08N01-010) Abbott RealTime BRAF V600 E/K/D Mutations Amplification Including Uracil-N-Glycosylase (UNG) (List No. 07N60-67) Abbott RealTime KRAS Control Kit (08N04-080) TargetPrep DNA FFPE Sample Preparation Kit I (List No. 08N01-005) Abbott RealTime BRAF V600 E/K/D Mutations ROW m2000rt Application CD-ROM (List No. 07N60-01) Abbott RealTime KRAS Amplification Reagent Kit (08N04-090) Abbott RealTime IDH1 Amplification Reagent Kit

    Establishment Types

    Manufacture Device in the United States for Export Only