# OYY · Leukemia Translocation Panel Multiplex Test

_ ·  · Class N_

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

## Overview

- **Product Code:** OYY
- **Device Name:** Leukemia Translocation Panel Multiplex Test
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow.  It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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