← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
ODW — Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
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.
DEVICE CLASS
Class II
REGULATION
21 CFR 862.3360
MEDICAL SPECIALTY
Clinical Toxicology
REVIEW PANEL
TX
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.