PJG — Cancer-Related Germline Gene Mutation Detection System Class III
FDA product code PJG covers "Cancer-Related Germline Gene Mutation Detection System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PJG
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
Definition
The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.