BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott MultiCollect Specimen Collection Kit 09K12

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    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

    Regulatory Submissions

    510(k) Number
    K140354

    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
    Device, Specimen Collection LIO
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Dna-Reagents, Neisseria LSL

    Proprietary Names

    Abbott MultiCollect Specimen Collection Kit 09K12 Abbott RealTime CT/NG Amplification Reagent Kit 08L07-91 Abbott RealTime CT/NG Control Kit 08L07-80 Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Cap (08L07-050) Abbott Real Time CT/NG Amplification Reagent Extended Use Including UNG (08L07-067) Abbott m2000 System Chlamydia Trachomatis and Neisseria Gonorrhoeae Application CD-ROM 06L98 Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae application CD ROM ver 5 (6L98-05) Abbott RealTime CT/NG Amplification Including UNG (08L07-66)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device