Luminex Molecular Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 21 products
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Total Devices21
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K242613 | NxTAG® Respiratory Pathogen Panel | OCC | 2024-10-02 | View |
| 510(k) | K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | QOF | 2024-03-11 | View |
| 510(k) | K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | OCC | 2019-12-11 | View |
| 510(k) | K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | PCH | 2019-11-12 | View |
| 510(k) | K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | 2019-11-04 | View |
| 510(k) | K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | 2018-11-30 | View |
| 510(k) | K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | 2018-11-30 | View |
| 510(k) | K170492 | xTAG CYP2D6 Kit v3 | NTI | 2017-08-11 | View |
| 510(k) | K163347 | xTAG Cystic Fibrosis 39 Kit v2 | NUA | 2016-12-15 | View |
| 510(k) | K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | NUA | 2016-12-15 | View |
| 510(k) | K131565 | XTAG CYP2C19 KIT V3 | NTI | 2013-09-11 | View |
| 510(k) | K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | NTI | 2013-05-21 | View |
| 510(k) | K121894 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX | PCH | 2013-03-21 | View |
| 510(k) | K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) | OCC | 2012-02-17 | View |
| 510(k) | K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) | OCC | 2011-09-01 | View |
| 510(k) | K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST | OCC | 2011-07-01 | View |
| 510(k) | K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) | NTI | 2010-08-26 | View |
| 510(k) | K083845 | XTAG CF60 KIT V2 | NUA | 2009-12-11 | View |
| 510(k) | K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | NUA | 2009-09-01 | View |
| 510(k) | K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 | OCC | 2009-06-25 | View |
No matching devices.
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