Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1650733

FEI Number

3002524000

Entity Name

Luminex Corporation

City/State/Country

AUSTIN, TX, US

Establishment Address

12212 Technology Blvd, AUSTIN, TX 78727, US

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

K152386

PMA Number

N/A

All Registered 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 FLEXMAP 3D xMAP® Sheath Fluid PLUS xMAP® Sheath Concentrate PLUS NxTAG Respiratory Pathogen Panel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-05-05
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2014-01-24
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
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
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2008-04-16
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2013-05-13
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2016-01-21

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
3006028115	Luminex Corporation	Northbrook, IL, US
3002777243	LUMINEX MOLECULAR DIAGNOSTICS, INC.	TORONTO Ontario, CA

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-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 1650733. Last updated year: 2026. Please use registration number 1650733 when referencing this establishment in official correspondence.