FDA 510(k) Applications Submitted by Luminex Molecular Diagnostics, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K081483 |
05/28/2008 |
XTAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K091667 |
06/09/2009 |
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K093420 |
11/03/2009 |
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| DEN070013 |
12/04/2007 |
ID-TAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K083845 |
12/24/2008 |
XTAG CF60 KIT V2 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K083846 |
12/24/2008 |
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K170492 |
02/17/2017 |
xTAG CYP2D6 Kit v3 |
Luminex Molecular Diagnostics, Inc. |
| K193167 |
11/15/2019 |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
Luminex Molecular Diagnostics, Inc. |
| K163336 |
11/28/2016 |
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR |
Luminex Molecular Diagnostics, Inc. |
| DEN130003 |
01/11/2013 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K130189 |
01/25/2013 |
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K121894 |
06/29/2012 |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K112199 |
08/01/2011 |
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K112781 |
09/26/2011 |
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K103776 |
12/27/2010 |
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K131565 |
05/30/2013 |
XTAG CYP2C19 KIT V3 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K140377 |
02/14/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K140647 |
03/13/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K191160 |
05/01/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
| K191161 |
05/01/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP) |
Luminex Molecular Diagnostics, Inc. |
| K152386 |
08/24/2015 |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K183023 |
11/01/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
| K183030 |
11/01/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
| K163347 |
11/28/2016 |
xTAG Cystic Fibrosis 39 Kit v2 |
Luminex Molecular Diagnostics, Inc. |
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