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

ODW · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3360

Classification

FDA Product Code: ODW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3360
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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 data

Cleared 510(k) submissions: 6
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown