Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

ODV · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7750

Classification

FDA Product Code: ODV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.7750
Review panel: HE
Medical specialty: Hematology
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 vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.

Market data

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

Source

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