NXG · Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
· Class 3
Overview
| Product Code | NXG |
|---|---|
| Device Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P050045 | DAKO TOP2A FISH PHARMDX KIT | Dako Denmark A/S | Jan 11, 2008 | APWD |
Top Applicants
- Dako Denmark A/S — 1 clearance
