Somatic Gene Mutation Detection System
The Somatic Gene Mutation Detection System is an in vitro diagnostic device that uses nucleic acid amplification and real-time detection to identify genetic mutations in DNA extracted from human tumor tissues. It is classified as Class 3 (FDA Class 3), the highest risk category, requiring Premarket Approval (PMA) before commercialization. The product code is OWD and it is reviewed under the pathology panel. No regulation number has been assigned, reflecting its novel high-risk classification.
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Basic Information
- Product Code
- OWD
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- PA
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.