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 Registration(s)

FDA Filings

Device
Company
DeviceDate
Luminex Molecular Diagnostics, Inc
xTAG® RVP FAST (Respiratory Viral Panel Fast) I025C01972020-01-03
Luminex Molecular Diagnostics, Inc
xTAG® RVP (Respiratory Viral Panel) I019C01112020-01-03
Luminex Molecular Diagnostics, Inc
NxTAG® Respiratory Pathogen Panel I051C04472020-01-03
Luminex Molecular Diagnostics, Inc.
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software2019-12-11
Luminex Molecular Diagnostics, Inc
xTAG® Gastrointestinal Pathogen Panel (GPP) I032C03162019-11-26
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® Cystic Fibrosis (CFTR) 39 kit v2 I027C02312019-10-28
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 I030E04432018-07-06
Luminex Molecular Diagnostics, Inc
xTAG® Cystic Fibrosis (CFTR) 60 kit v2 I024C01812018-07-06
Luminex Molecular Diagnostics, Inc
xTAG® Cystic Fibrosis Mutation Detection Kit I006C00682018-07-06
Luminex Molecular Diagnostics, Inc
xTAG® CYP2C19 Kit v3 I046B04272018-07-06
Luminex Molecular Diagnostics, Inc
xTAG® CYP2D6 Kit v3 I030B03732018-07-06
Luminex Molecular Diagnostics, Inc.
XTAG CYP2D6 Kit V32017-08-11
Luminex Molecular Diagnostics, Inc.
XTAG Cystic Fibrosis 39 Kit V22016-12-15
Luminex Molecular Diagnostics, Inc.
XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR2016-12-15
LUMINEX MOLECULAR DIAGNOSTICS, INC.
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software2015-12-17
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 V32013-09-11
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 MAGPIX2013-03-21
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)2013-01-14
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 FAST2011-07-01
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 V22009-12-11
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E02672009-09-01
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-01162009-06-25
LUMINEX MOLECULAR DIAGNOSTICS, INC.
XTAG RESPIRATORY VIRAL PANEL2008-06-25
LUMINEX MOLECULAR DIAGNOSTICS, INC.
ID-TAG RESPIRATORY VIRAL PANEL2008-01-03

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