PMA P150025

Device: PD-L1 IHC 28-8 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150025
Supplement: S015
Product code: PLS
Decision date: 2026-07-01
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval for the PD-L1 IHC 28-8 pharmDx for expanding the indications to include use as an aid in identifying patients with esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma for treatment with OPDIVO (nivolumab) or OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy).

Current openFDA PMA Record#

Device: PD-L1 IHC 28-8 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150025
Supplement: S018
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2026-07-01
Decision code: APPR
Date received: 2026-01-02
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the PD-L1 IHC 28-8 pharmDx for expanding the indications to include use as an aid in identifying patients with esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma for treatment with OPDIVO (nivolumab) or OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy).