Home›Canada›LUMINEX MOLECULAR DIAGNOSTICS, INC.

LUMINEX MOLECULAR DIAGNOSTICS, INC.

Canada · Toronto

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 2Class II 14Class III 0

plus 19 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class II 3Class III 3

13 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States19 registration records, 26 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 1 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: LUMINEX MOLECULAR DIAGNOSTICS, INC.

FDA 510(k) clearances by year

22008

32009

12010

22011

12012

42013

22014

12015

22016

12017

22018

32019

22024

FDA listed device types

showing 8 of 16

Clinical Sample Concentrator 1General Purpose Reagent 1Parainfluenza Multiplex Nucleic Acid Assay 1Respiratory Virus Panel Nucleic Acid Assay System 1Human Metapneumovirus (Hmpv) Rna Assay System 1Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna 1System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection 1Influenza A Virus Subtype Differentiation Nucleic Acid Assay 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242613	NxTAG® Respiratory Pathogen Panel	2024-10-02
US	K231758	NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)	2024-03-11
US	K193167	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	2019-12-11
CA	71958	X TAG CYSTIC FIBROSIS KIT (CYSTIC FIBROSIS MUTATION DETECTION KIT)	Class III
CA	77721	XTAG RESPIRATORY VIRAL PANEL	Class II
CA	80481	XTAG RVP FAST (RESPIRATORY VIRAL PANEL FAST)	Class II

LUMINEX MOLECULAR DIAGNOSTICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies