PMA P150013S033

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S033
Product code: PLS
Decision date: 2026-02-10
Classification: Pathology
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval for the PD-L1 IHC 22C3 pharmDx for expanding the indications to include use as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) for treatment with KEYTRUDA® (pembrolizumab).

Current openFDA PMA Record#

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S033
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2026-02-10
Decision code: APPR
Date received: 2025-09-29
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the PD-L1 IHC 22C3 pharmDx for expanding the indications to include use as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) for treatment with KEYTRUDA® (pembrolizumab).