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.
| Device Type ID | 5040 |
| Device Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Physical State | Assay Kit Contains Pre-treatment Solution, TOP2A/CEN-17 Probe Mix, Buffers, And Fluorescence Mounting Medium |
| Technical Method | Fluorescence In Situ Hybridization, Manual Method |
| Target Area | Formalin-fixed, Paraffin-embeded Human Breast Cancer Tissue Specimen |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NXG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |