BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alinity m System

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    5

    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
    K202977

    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
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Real Time Nucleic Acid Amplification System OOI
    Dna-Reagents, Neisseria LSL

    Proprietary Names

    Alinity m System Alinity m Diluent Solution Alinity m STI Application Specification File Alinity m Ethanol Solution Alinity m STI Control Kit Alinity m Sample Prep Kit 1 Alinity m Lysis Solution Alinity m Multi-Collect Specimen Collection Kit Alinity m STI Amplification Reagent Kit Alinity m Vapor Barrier Solution Alinity m Bottle for Ethanol Use

    Establishment Types

    Manufacture Medical Device