Luminex Molecular Diagnostics, Inc. - FDA 510(k) Cleared Devices
26
Total
22
Cleared
2
Denied
FDA 510(k) cleared devices by Luminex Molecular Diagnostics, Inc. Microbiology ✕
18 devices
Cleared
Oct 02, 2024
NxTAG® Respiratory Pathogen Panel
Microbiology
29d
Cleared
Mar 11, 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
Microbiology
269d
Cleared
Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
Microbiology
26d
Cleared
Nov 12, 2019
xTAG Gastrointestinal Pathogen Panel (GPP)
Microbiology
195d
Cleared
Nov 04, 2019
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
Microbiology
187d
Cleared
Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
Microbiology
29d
Cleared
Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
Microbiology
29d
Cleared
Dec 17, 2015
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
Microbiology
115d
Cleared
Oct 24, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
Microbiology
225d
Cleared
Sep 16, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
Microbiology
214d
Cleared
Mar 21, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP...
Microbiology
265d
Not Cleared
Jan 14, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR...
Microbiology
3d
Cleared
Feb 17, 2012
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
Microbiology
144d
Cleared
Sep 01, 2011
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
Microbiology
31d
Cleared
Jul 01, 2011
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
Microbiology
186d
Cleared
Jun 25, 2009
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112,...
Microbiology
16d
Cleared
Jun 25, 2008
XTAG RESPIRATORY VIRAL PANEL
Microbiology
28d
Not Cleared
Jan 03, 2008
ID-TAG RESPIRATORY VIRAL PANEL
Microbiology
30d