BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    LUMINEX MOLECULAR DIAGNOSTICS, INC.

    Reg #: 3002777243 · FEI: 3002777243 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    16

    Registration Details

    Registration Name
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Registration Number
    3002777243
    FEI Number
    3002777243
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    439 UNIVERSITY AVE.
    City
    TORONTO Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K231758

    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
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection NUA
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Clinical Sample Concentrator JJH
    Instrumentation For Clinical Multiplex Test Systems NSU
    Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna NXD
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Chlamydophila Pneumoniae Dna Assay System OZY
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Real Time Nucleic Acid Amplification System OOI
    Mycoplasma Pneumoniae Dna Assay System OZX
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    General Purpose Reagent PPM
    Drug Metabolizing Enzyme Genotyping Systems NTI

    Proprietary Names

    NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) Xtag Cystic Fibrosis 60 Kit V2 Gastrointestinal Pathogen Panel (GPP) xTAG Respiratory Viral Panel xTAG Cystic Fibrosis 39 kit v2 NXTAG Respiratory Pathogen Panel xTAG Gastrointestinal Pathogen Panel xTAG GPP Xtag Cystic Fibrosis 39 Kit V2 NxTAG® Respiratory Pathogen Panel xTAG® Gastrointestinal Pathogen Panel (GPP) xTAG® Data Analysis Software (TDAS GPP) xTAG TAG-IT xTAG CYP2C19 KIT V3 NxTAG Respiratory Pathogen Panel xTAG Cystic Fibrosis 60 kit v2

    Establishment Types

    Manufacture Medical Device