PMA P150013S031

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S031
Product code: PLS
Decision date: 2026-03-19
Classification: Pathology
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval to migrate the PD-L1 IHC 22C3 pharmDx assay using the Autostainer Link 48 for esophageal squamous cell carcinoma (ESCC) with CPS>=10, triple-negative breast cancer (TNBC) with CPS>=10, cervical cancer with CPS>=1, and gastric or gastroesophageal junction (GEJ) adenocarcinoma with CPS>=1 indication to the Dako Omnis automated staining system.

Current openFDA PMA Record#

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S031
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2026-03-19
Decision code: APPR
Date received: 2025-07-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to migrate the PD-L1 IHC 22C3 pharmDx assay using the Autostainer Link 48 for esophageal squamous cell carcinoma (ESCC) with CPS>=10, triple-negative breast cancer (TNBC) with CPS>=10, cervical cancer with CPS>=1, and gastric or gastroesophageal junction (GEJ) adenocarcinoma with CPS>=1 indication to the Dako Omnis automated staining system.