Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006028115

FEI Number

3006028115

Entity Name

Luminex Corporation

City/State/Country

Northbrook, IL, US

Establishment Address

4088 Commercial Avenue, Northbrook, IL 60062, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K143653

PMA Number

N/A

All Registered Proprietary Names

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP LIAISON PLEX Respiratory Flex Assay LIAISON PLEX Gram-Negative Blood Culture Assay LIAISON PLEX® Gram-Positive Blood Culture Assay LIAISON PLEX Yeast Blood Culture Assay Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test LIAISON PLEX Gastrointestinal Flex Assay Verigene System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2016-08-16
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Microbiology	Class 2	866.3365	2016-08-16
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-08-16
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2016-08-16
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2016-08-16
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-05-15
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2024-05-15
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2024-05-15
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-05-15
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-05-15
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2024-05-15
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-05-15
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2024-05-15
OZY	Chlamydophila Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2024-05-15
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-05-15
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Microbiology	Class 2	866.3365	2025-06-05
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-06-05
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-07-07
PAM	Gram-Positive Bacteria And Their Resistance Markers	Microbiology	Class 2	866.3365	2025-07-07
PEO	Fungal Organisms, Nucleic Acid-Based Assay	Microbiology	Class 2	866.3365	2024-10-16
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-10-16
PAM	Gram-Positive Bacteria And Their Resistance Markers	Microbiology	Class 2	866.3365	2016-08-16
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2026-06-02
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2026-06-02
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-08-16
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-08-16
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2016-08-16
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-08-16
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-08-16
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2016-08-16
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2016-08-16

Official Correspondent

Mari Meyer

US Agent Details

No US Agent registered (Local establishment).

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
3002777243	LUMINEX MOLECULAR DIAGNOSTICS, INC.	TORONTO Ontario, CA

Related Recall Records

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

Similar Registrations

Registration Number	Establishment Name	Location
3005370583	KORVIS LLC (DBA Ascential Medical & Life Sciences)	Corvallis, OR, US
3005269352	Invetech Pty Ltd	Mount Waverley Victoria, AU
3002773840	BioFire Diagnostics, LLC	Salt Lake City, UT, US
3007361513	EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, DE
2243471	ROCHE MOLECULAR SYSTEMS, INC.	Branchburg, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006028115. Last updated year: 2026. Please use registration number 3006028115 when referencing this establishment in official correspondence.