# PLS · Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

_ ·  · Class 3_

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

## Overview

- **Product Code:** PLS
- **Device Name:** Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens.  The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160046](/device/P160046.md) | VENTANA PD-L1 (SP263) ASSAY | Ventana Medical Systems, Inc. | May 1, 2017 | APPR |
| [P160006](/device/P160006.md) | VENTANA PD-L1 (SP142) Assay | Ventana Medical Systems, Inc. | Oct 18, 2016 | APCB |
| [P160002](/device/P160002.md) | VENTANA PD-L1(SP142) CDX ASSAY | Ventana Medical Systems, Inc. | May 18, 2016 | APPR |
| [P150027](/device/P150027.md) | PD-L1 IHC 28-8 pharmDx | Dako North America, Inc. | Jan 23, 2016 | APCB |
| [P150013](/device/P150013.md) | PD-L1 IHC 22C3 PHARMDX | Agilent Technologies, Inc. | Oct 2, 2015 | APPR |

## Top Applicants

- Ventana Medical Systems, Inc. — 3 clearances
- Agilent Technologies, Inc. — 1 clearance
- Dako North America, Inc. — 1 clearance

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

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