# QQT · Immunohistochemistry Assay, Antibody, Ki-67

_ ·  · Class 3_

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

## Overview

- **Product Code:** QQT
- **Device Name:** Immunohistochemistry Assay, Antibody, Ki-67
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens.  The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210026](/device/P210026.md) | Ki-67 IHC pharmDx | Agilent Technologies, Inc. | Oct 12, 2021 | APPR |

## Top Applicants

- Agilent Technologies, Inc. — 1 clearance

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

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