Luminex Molecular Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Luminex Molecular Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
GUDID 00840487101872 Luminex Molecular Diagnostics, Inc	NxTAG® Respiratory Pathogen Panel v2 I055C0465	2024-06-28
GUDID 00840487100486 Luminex Molecular Diagnostics, Inc	xTAG® RVP FAST (Respiratory Viral Panel Fast) I025C0197	2020-01-03
GUDID 00840487100462 Luminex Molecular Diagnostics, Inc	xTAG® RVP (Respiratory Viral Panel) I019C0111	2020-01-03
GUDID 00840487100417 Luminex Molecular Diagnostics, Inc	NxTAG® Respiratory Pathogen Panel I051C0447	2020-01-03
PMN K193167 Luminex Molecular Diagnostics, Inc.	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	2019-12-11
GUDID 00840487100493 Luminex Molecular Diagnostics, Inc	xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316	2019-11-26
PMN K191161 Luminex Molecular Diagnostics, Inc.	XTAG Gastrointestinal Pathogen Panel (GPP)	2019-11-12
PMN K191160 Luminex Molecular Diagnostics, Inc.	XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)	2019-11-04
GUDID 00840487100141 Luminex Molecular Diagnostics, Inc	xTAG® Cystic Fibrosis (CFTR) 39 kit v2 I027C0231	2019-10-28
PMN K183030 Luminex Molecular Diagnostics, Inc.	XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)	2018-11-30
PMN K183023 Luminex Molecular Diagnostics, Inc.	XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)	2018-11-30
GUDID 00840487101025 Luminex Molecular Diagnostics, Inc	xTAG® CYP2D6 Kit v3 I030E0443	2018-07-06
GUDID 00840487100479 Luminex Molecular Diagnostics, Inc	xTAG® Cystic Fibrosis (CFTR) 60 kit v2 I024C0181	2018-07-06
GUDID 00840487100455 Luminex Molecular Diagnostics, Inc	xTAG® Cystic Fibrosis Mutation Detection Kit I006C0068	2018-07-06
GUDID 00840487100172 Luminex Molecular Diagnostics, Inc	xTAG® CYP2C19 Kit v3 I046B0427	2018-07-06
GUDID 00840487100134 Luminex Molecular Diagnostics, Inc	xTAG® CYP2D6 Kit v3 I030B0373	2018-07-06
PMN K170492 Luminex Molecular Diagnostics, Inc.	XTAG CYP2D6 Kit V3	2017-08-11
PMN K163347 Luminex Molecular Diagnostics, Inc.	XTAG Cystic Fibrosis 39 Kit V2	2016-12-15
PMN K163336 Luminex Molecular Diagnostics, Inc.	XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR	2016-12-15
PMN K152386 LUMINEX MOLECULAR DIAGNOSTICS, INC.	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	2015-12-17
PMN K140647 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)	2014-10-24
PMN K140377 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)	2014-09-16
PMN K131565 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CYP2C19 KIT V3	2013-09-11
PMN K130189 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)	2013-05-21
PMN K121894 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX	2013-03-21
De Novo DEN130003 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)	2013-01-14
PMN K112781 LUMINEX MOLECULAR DIAGNOSTICS, INC.	TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)	2012-02-17
PMN K112199 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)	2011-09-01
PMN K103776 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST	2011-07-01
PMN K093420 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)	2010-08-26
PMN K083845 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CF60 KIT V2	2009-12-11
PMN K083846 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	2009-09-01
PMN K091667 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116	2009-06-25
PMN K081483 LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG RESPIRATORY VIRAL PANEL	2008-06-25
De Novo DEN070013 LUMINEX MOLECULAR DIAGNOSTICS, INC.	ID-TAG RESPIRATORY VIRAL PANEL	2008-01-03

Related Finance Registrations

CAGE Code	L4908	LUMINEX MOLECULAR DIAGNOSTICS, INC
S.A.M. Registration	L4908 [255371916]	LUMINEX MOLECULAR DIAGNOSTICS, INC