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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2014 | Nanosphere, Inc. Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Terminated |
NTI | K120466 |
| Aug 31, 2011 | Luminex Corporation xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373
The xTAG CYP2D6 Kit v3 is a device Terminated |
NTI | K093420 |
| Apr 11, 2007 | Roche Molecular Systems, Inc. AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc. Terminated |
NTI | None listed |
| Apr 11, 2007 | Roche Molecular Systems, Inc. AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics Terminated |
NTI | K043576 |
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