BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Luminex Corporation

    Reg #: 1650733 · FEI: 3002524000 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    10

    Registration Details

    Registration Name
    Luminex Corporation
    Registration Number
    1650733
    FEI Number
    3002524000
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12212 Technology Blvd
    City
    AUSTIN
    State
    TX
    ZIP
    78727
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160517

    Owner / Operator

    Firm Name
    Luminex Corporation
    Operator Number
    9032042
    Address
    12212 Technology Blvd.
    City
    Austin
    State
    TX
    Postal Code
    78727
    Country
    US
    Correspondent
    Mari Meyer

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Instrumentation For Clinical Multiplex Test Systems NSU
    Clinical Sample Concentrator JJH
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Bordetella Pertussis Dna Assay System OZZ
    Respiratory Virus Panel Nucleic Acid Assay System OCC

    Proprietary Names

    SYNCT FLEXMAP 3D Gastrointestinal Pathogen Panel (GPP) Verigene System Luminex 100 Luminex 100/200 Luminex 200 xMAP® Sheath Concentrate PLUS xMAP® Sheath Fluid PLUS NxTAG Respiratory Pathogen Panel MAGPIX MAGPIX® Drive Fluid PLUS (4PK) LIAISON PLEX System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)