PMA P150013S028

Device: PD-L1 IHC 22C3 pharmDx (Dako Omnis)
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S028
Product code: PLS
Decision date: 2025-08-04
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 the head and neck squamous cell carcinoma (HNSCC) indication to the Dako Omnis automated staining system.

Current openFDA PMA Record#

Device: PD-L1 IHC 22C3 pharmDx (Dako Omnis)
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S028
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2025-08-04
Decision code: APPR
Date received: 2024-11-22
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 the head and neck squamous cell carcinoma (HNSCC) indication to the Dako Omnis automated staining system.