BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    NXTAG Respiratory Pathogen Panel

    Reg #: 3002777243 · FEI: 3002777243 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Registration Number
    3002777243
    FEI Number
    3002777243
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    439 UNIVERSITY AVE.
    City
    TORONTO Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K242613

    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

    US Agent

    Business Name
    LUMINEX CORP.
    Contact Name
    Mari Meyer
    Address
    12212 TECHNOLOGY BLVD.
    City
    AUSTIN
    State
    TX
    ZIP
    78727
    Country
    US
    Email
    [email protected]
    Phone
    715 4107149 ext. 0

    Products

    Device Name Product Code
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Chlamydophila Pneumoniae Dna Assay System OZY
    Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna NXD
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Mycoplasma Pneumoniae Dna Assay System OZX
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    NXTAG Respiratory Pathogen Panel

    Establishment Types

    Manufacture Medical Device