

# PAN · Braf Mutation Kit

_ ·  · Class N_

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

## Overview

- **Product Code:** PAN
- **Device Name:** Braf Mutation Kit
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue.  It is intended to aid in the treatment decisions and risk stratification of patients diagnosed with colorectal or papillary thyroid cancer.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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