NXG — Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion Class III
FDA product code NXG covers "Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- NXG
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
Definition
Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.