Company · CA
Luminex Molecular Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2024. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 11 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 9 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 4 |
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 4 |
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | 1 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2024 | K242613 | NxTAG® Respiratory Pathogen Panel Luminex Molecular Diagnostics, Inc., CA | OCC |
| Mar 11, 2024 | K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) Luminex Molecular Diagnostics, Inc., CA | QOF |
| Dec 11, 2019 | K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software Luminex Molecular Diagnostics, Inc., CA | OCC |
| Nov 12, 2019 | K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Nov 4, 2019 | K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Nov 30, 2018 | K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Nov 30, 2018 | K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Aug 11, 2017 | K170492 | xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc., CA | NTI |
| Dec 15, 2016 | K163347 | xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics, Inc., CA | NUA |
| Dec 15, 2016 | K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR Luminex Molecular Diagnostics, Inc., CA | NUA |
| Dec 17, 2015 | K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software Luminex Molecular Diagnostics, Inc., CA | OCC |
| Oct 24, 2014 | K140647 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Sep 16, 2014 | K140377 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Sep 11, 2013 | K131565 | XTAG CYP2C19 KIT V3 Luminex Molecular Diagnostics, Inc., CA | NTI |
| May 21, 2013 | K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) Luminex Molecular Diagnostics, Inc., CA | NTI |
| Mar 21, 2013 | K121894 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX Luminex Molecular Diagnostics, Inc., CA | PCH |
| Jan 14, 2013 | DEN130003 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) Luminex Molecular Diagnostics, Inc., CA | PCH |
| Feb 17, 2012 | K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) Luminex Molecular Diagnostics, Inc., CA | OCC |
| Sep 1, 2011 | K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) Luminex Molecular Diagnostics, Inc., CA | OCC |
| Jul 1, 2011 | K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST Luminex Molecular Diagnostics, Inc., CA | OCC |
| Aug 26, 2010 | K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) Luminex Molecular Diagnostics, Inc., CA | NTI |
| Dec 11, 2009 | K083845 | XTAG CF60 KIT V2 Luminex Molecular Diagnostics, Inc., CA | NUA |
| Sep 1, 2009 | K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 Luminex Molecular Diagnostics, Inc., CA | NUA |
| Jun 25, 2009 | K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 Luminex Molecular Diagnostics, Inc., CA | OCC |
| Jun 25, 2008 | K081483 | XTAG RESPIRATORY VIRAL PANEL Luminex Molecular Diagnostics, Inc., CA | OCC |
| Jan 3, 2008 | DEN070013 | ID-TAG RESPIRATORY VIRAL PANEL Luminex Molecular Diagnostics, Inc., CA | OCC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2024 | Luminex Molecular Diagnostics Inc NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 Open, Classified |
QLT | None listed |
| Oct 9, 2024 | Luminex Molecular Diagnostics Inc NxTAG Respiratory Pathogen Panel, REF: I051C0447 Open, Classified |
OCC | K152386 K193167 |
| Jul 16, 2019 | Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (RVP):
Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111
in vitro diagnostic test Open, Classified |
OCC | K081483 K091667 +2 |
| Feb 22, 2019 | Luminex Molecular Diagnostics xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human s Open, Classified |
PCH | K140377 |