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

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.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 (20 of 20)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150025S018](/device/P150025S018.md) | PD-L1 IHC 28-8 pharmDx | Agilent Technologies, Inc. | Jul 1, 2026 | APPR |
| [P150013S032](/device/P150013S032.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Feb 11, 2026 | APPR |
| [P150013S033](/device/P150013S033.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Feb 10, 2026 | APPR |
| [P160046S013](/device/P160046S013.md) | VENTANA PD-L1 (SP263) Assay | Ventana Medical Systems, Inc. | Mar 1, 2023 | APPR |
| [P160046S010](/device/P160046S010.md) | VENTANA PD-L1 (SP263) Assay | Ventana Medical Systems, Inc. | Oct 15, 2021 | APPR |
| [P150013S020](/device/P150013S020.md) | PD-L1 IHC 22C3 pharmDX | Agilent Technologies, Inc. | Nov 13, 2020 | APPR |
| [P150025S013](/device/P150025S013.md) | PD-L1 IHC 28-8 pharmDx | Agilent Technologies, Inc. | May 15, 2020 | APPR |
| [P150013S016](/device/P150013S016.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Jul 30, 2019 | APPR |
| [P150013S014](/device/P150013S014.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Jun 10, 2019 | APPR |
| [P160002S009](/device/P160002S009.md) | VENTANA PD-L1(SP142) Assay. | Ventana Medical Systems, Inc. | Mar 8, 2019 | APPR |
| [P150013S011](/device/P150013S011.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Aug 16, 2018 | APPR |
| [P150013S009](/device/P150013S009.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Jun 12, 2018 | APPR |
| [P150013S006](/device/P150013S006.md) | PD-L1 IHC 22C3 pharmDx | Agilent Technologies, Inc. | Sep 22, 2017 | APPR |
| [P150025S003](/device/P150025S003.md) | PD-L1 IHC 28-8 PHARMDX | Agilent Technologies, Inc. | Sep 15, 2017 | APPR |
| [P160046](/device/P160046.md) | VENTANA PD-L1 (SP263) ASSAY | Ventana Medical Systems, Inc. | May 1, 2017 | APPR |
| [P150013S001](/device/P150013S001.md) | PD-L1 IHC 22C3 PHARMDX | Agilent Technologies, Inc. | Oct 24, 2016 | 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

- Agilent Technologies, Inc. — 13 clearances
- Ventana Medical Systems, Inc. — 6 clearances
- Dako North America, Inc. — 1 clearance

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

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