ODW
6 FDA 510(k) clearances · Product code
199 daysmedian time to decision
464 days90th percentile
6clearances measured
FDA profile
- Official device name
- Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3360
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TruDiagnosis System (K183530) | Akonni Biosystems, Inc. | 2019-05-24 |
| eSensor Warfarin Sensitivity Saliva Test (K152612) | Genmark Diagnostics, Incorporated | 2016-05-26 |
| EQ-PRC LC WARFARIN GENOTYPING KIT (K073071) | Trimgen Corporation | 2009-02-06 |
| ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (K073720) | Osmetech Molecular Diagnostics | 2008-07-17 |
| INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN (K073014) | Autogenomics, Incorporated | 2008-01-23 |
| VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST (K070804) | Nanosphere, Inc. | 2007-09-17 |
Track ODW automatically
Every clearance here is in the API, with alerts when new ones post.