Panels › Clinical Toxicology › Product code NTI · Class 2
Drug Metabolizing Enzyme Genotyping Systems
Regulation 862.3360
0510(k)s in 12 months (11 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in NTI
| Company | 510(k)s | Recalls |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 4 | 0 |
| Roche Molecular Systems, Inc. | 2 | 2 |
| Nanosphere, Inc. | 1 | 1 |
| Autogenomics, Incorporated | 1 | 0 |
| Genomadix, Inc. | 1 | 0 |
| Luminex Corporation | 0 | 1 |
| Spartan Bioscience, Inc. | 1 | 0 |
| Third Wave Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 2023 | K220026 | Genomadix Cube CYP2C19 System Genomadix, Inc., CA | NTI |
| Aug 11, 2017 | K170492 | xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc., CA | NTI |
| Sep 11, 2013 | K131565 | XTAG CYP2C19 KIT V3 Luminex Molecular Diagnostics, Inc., CA | NTI |
| Aug 12, 2013 | K123891 | SPARTAN RX CYP2C19 TEST SYSTEM Spartan Bioscience, Inc. | NTI |
| May 21, 2013 | K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) Luminex Molecular Diagnostics, Inc., CA | NTI |
| Nov 6, 2012 | K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) Nanosphere, Inc. | NTI |
| Oct 25, 2010 | K101683 | INFINITI CYP2C19 ASSAY Autogenomics, Incorporated | NTI |
| Aug 26, 2010 | K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) Luminex Molecular Diagnostics, Inc., CA | NTI |
| Aug 18, 2005 | K051824 | INVADER UGT1A1 MOLECULAR ASSAY Third Wave Technologies, Inc. | NTI |
| Jan 10, 2005 | K043576 | ROCHE AMPLICHIP CYP450 TEST Roche Molecular Systems, Inc. | NTI |
| Dec 23, 2004 | DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 Roche Molecular Systems, Inc. | NTI |
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