PQP — Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Class III
FDA product code PQP covers "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PQP
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
Definition
A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.