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Drug Metabolizing Enzyme Genotyping Systems
FDA product code NTI · Class 2 · Clinical Toxicology
22
Registered devices
6
Adverse events
4
Recalls
11
510(k) clearances
Devices with this code
Genomadix Cube CYP2C19 — Genomadix IncSpartan RX CYP2C19 System — Spartan Bioscience IncSpartan RX CYP2C19 System — Spartan Bioscience IncSpartan RX CYP2C19 System — Spartan Bioscience IncINFINITI® CYP2C19 Amplification Mix — AUTOGENOMICS, INCGenomadix Cube CYP2C19 — Genomadix IncINFINITI® CYP2C19 Intellipac® Reagent Module — AUTOGENOMICS, INCxTAG® CYP2D6 Kit v3 — Luminex Molecular Diagnostics, IncSpartan RX CYP2C19 System — Spartan Bioscience IncSpartan RX CYP2C19 System — Spartan Bioscience IncGenomadix Cube CYP2C19 — Genomadix IncxTAG® CYP2C19 Kit v3 — Luminex Molecular Diagnostics, IncGenomadix Cube CYP2C19, — Genomadix IncGenomadix Cube CYP2C19 — Genomadix IncSpartan RX CYP2C19 System — Spartan Bioscience IncSpartan RX CYP2C19 System — Spartan Bioscience IncSpartan RX CYP2C19 System — Spartan Bioscience IncSpartan RX CYP2C19 System — Spartan Bioscience IncxTAG® CYP2D6 Kit v3 — Luminex Molecular Diagnostics, IncINFINITI® CYP2C19 BioFilmChip® Microarray Magazine — AUTOGENOMICS, INCSpartan RX CYP2C19 System — Spartan Bioscience IncGenomadix Cube CYP2C19 — Genomadix Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-18 | Nanosphere, Inc. | Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which |
| 2011-05-24 | Luminex Corporation | Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays. |
| 2007-03-09 | Roche Molecular Systems, Inc. | The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" se |
| 2007-03-09 | Roche Molecular Systems, Inc. | The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" se |
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