OWD — Somatic Gene Mutation Detection System Class III
FDA product code OWD covers "Somatic Gene Mutation Detection System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OWD
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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.