ODW

Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

Product code: ODW
Device name: Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device class: Class 2
21 CFR: 21 CFR 862.3360
Medical specialty: Clinical Toxicology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 6 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ODW

Classification and pathway per current FDA publications. Data from openFDA (CC0).