LUMINEX MOLECULAR DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3002777243	3002777243	LUMINEX MOLECULAR DIAGNOSTICS, INC.	1	N	2026-01-01	439 UNIVERSITY AVE. TORONTO Ontario CA M5G 1Y8

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
54093	1947463712	K242613	NxTAG® Respiratory Pathogen Panel	OCC	2024-10-02
54093	1727233441	K231758	NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)	QOF	2024-03-11
54093	1144124608	K193167	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	OCC	2019-12-11
54093	1923683921	K191161	xTAG Gastrointestinal Pathogen Panel (GPP)	PCH	2019-11-12
54093	1865319710	K191160	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	PCH	2019-11-04
54093	1609194887	K183030	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	PCH	2018-11-30
54093	1870390410	K183023	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	PCH	2018-11-30
54093	1506245622	K170492	xTAG CYP2D6 Kit v3	NTI	2017-08-11
54093	1042642641	K163347	xTAG Cystic Fibrosis 39 Kit v2	NUA	2016-12-15
54093	1489899718	K163336	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	NUA	2016-12-15
54093	1680564076	K152386	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	OCC	2015-12-17
54093	1449927313	K140647	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)	PCH	2014-10-24
54093	1677106998	K140377	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)	PCH	2014-09-16
54093	1157960488	K131565	XTAG CYP2C19 KIT V3	NTI	2013-09-11
54093	1585803848	K130189	XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)	NTI	2013-05-21
54093	1653495788	K121894	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX	PCH	2013-03-21
54093	1238965019	K093420	XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)	NTI	2010-08-26
54093	1618704888	K083846	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	NUA	2009-09-01
54093	1548656302	K083845	XTAG CF60 KIT V2	NUA	2009-12-11
54093	2040700212	DEN130003	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)	PCH	2013-01-14
54093	1214056701	DEN070013	ID-TAG RESPIRATORY VIRAL PANEL	OCC	2008-01-03
54093	1583147392

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PCH	8	2019-11-12
OCC	4	2024-10-02
NTI	4	2017-08-11
NUA	4	2016-12-15
QOF	1	2024-03-11

PMN#

NxTAG® Respiratory Pathogen Panel
2024-10-02
Luminex Molecular Diagnostics, Inc.
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
2024-03-11
Luminex Molecular Diagnostics, Inc.
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
2019-12-11
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP)
2019-11-12
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)
2019-11-04
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)
2018-11-30
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)
2018-11-30
Luminex Molecular Diagnostics, Inc.
XTAG CYP2D6 Kit V3
2017-08-11
Luminex Molecular Diagnostics, Inc.
XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR
2016-12-15
Luminex Molecular Diagnostics, Inc.
XTAG Cystic Fibrosis 39 Kit V2
2016-12-15
Luminex Molecular Diagnostics, Inc.
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
2015-12-17
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
2014-10-24
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
2014-09-16
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG CYP2C19 KIT V3
2013-09-11
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
2013-05-21
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
2013-03-21
LUMINEX MOLECULAR DIAGNOSTICS, INC.
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
2012-02-17
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
2011-09-01
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
2011-07-01
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
2010-08-26
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG CF60 KIT V2
2009-12-11
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
2009-09-01
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
2009-06-25
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG RESPIRATORY VIRAL PANEL
2008-06-25
LUMINEX MOLECULAR DIAGNOSTICS, INC.