# NXG · Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/NXG

## Overview

- **Product Code:** NXG
- **Device Name:** Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## 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](/device/P050045.md) | DAKO TOP2A FISH PHARMDX KIT | Dako Denmark A/S | Jan 11, 2008 | APWD |

## Top Applicants

- Dako Denmark A/S — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/NXG](https://fda.innolitics.com/productcode/NXG)

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