OWD

Somatic Gene Mutation Detection System

Product code: OWD
Device name: Somatic Gene Mutation Detection System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.

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

Official FDA classification page: OWD

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