Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002777243

FEI Number

3002777243

Entity Name

LUMINEX MOLECULAR DIAGNOSTICS, INC.

City/State/Country

TORONTO Ontario, CA

Establishment Address

439 UNIVERSITY AVE., TORONTO Ontario M5G 1Y8, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Luminex Corporation (Owner Number: 9032042)

Owner / Operator Contact Address

12212 Technology Blvd., Austin, TX 78727, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131565

PMA Number

N/A

All Registered Proprietary Names

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) Xtag Cystic Fibrosis 60 Kit V2 Gastrointestinal Pathogen Panel (GPP) xTAG Respiratory Viral Panel Gastrointestinal Pathogen Panel (GPP) 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® Gastrointestinal Pathogen Panel (GPP) xTAG Gastrointestinal Pathogen Panel xTAG TAG-IT xTAG CYP2C19 KIT V3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-05-15
NUA	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection	Immunology	Class 2	866.5900	2017-02-03
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2013-05-13
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2008-02-01
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2013-05-13
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2013-05-13
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2013-05-13
NUA	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection	Immunology	Class 2	866.5900	2010-06-15
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2024-11-26
NXD	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna	Microbiology	Class 2	866.3332	2024-11-26
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-11-26
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-11-26
OZY	Chlamydophila Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2024-11-26
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2024-11-26
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-11-26
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2024-11-26
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-11-26
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2014-09-25
NUA	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection	Immunology	Class 2	866.5900	2017-02-03
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2019-12-23
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2019-11-14
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2018-12-03
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2014-11-11
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2004-04-09
NTI	Drug Metabolizing Enzyme Genotyping Systems	Clinical Toxicology	Class 2	862.3360	2013-11-01

Official Correspondent

Mari Meyer

US Agent Details

Mari Meyer Business: LUMINEX CORP. Email: mari.meyer@diasorin.com Phone: (715) 4107149

Related Public Records

Same Entity

Luminex Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1650733	Luminex Corporation	AUSTIN, TX, US
3006028115	Luminex Corporation	Northbrook, IL, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0043-2025	Luminex Molecular Diagnostics Inc	N	NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002777243. Last updated year: 2026. Please use registration number 3002777243 when referencing this establishment in official correspondence.