Product code ODW— Clinical Toxicology
EQ-PRC LC WARFARIN GENOTYPING KIT
- Classification name
- Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Device class
- Class 2
- Regulation
- 21 CFR 862.3360
- Advisory panel
- Clinical Toxicology
- Total cleared
- 6
- First cleared
- Most recent
FDA classification 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.”
Market context for product code ODW
FDA has cleared devices under product code ODW between 2007 and 2019, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2016
- 2009
- 2008
- 2007
Top applicants under product code ODW
Recent clearances under product code ODW
- K183530 — TruDiagnosis System
- K152612 — eSensor Warfarin Sensitivity Saliva Test
- K073071 — EQ-PRC LC WARFARIN GENOTYPING KIT
- K073720 — ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
- K073014 — INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
- K070804 — VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.