|
Device | PD-L1 IHC 22C3 pharmDx |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | Agilent Technologies, Inc. 5301 Stevens Creek Blvd Santa Clara, CA 95051 |
PMA Number | P150013 |
Supplement Number | S026 |
Date Received | 06/12/2023 |
Decision Date | 07/05/2023 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to Instructions for Use and manufacturing quality control technical procedure intended to mitigate nonspecific nuclear staining in formalin-fixed, paraffin-embedded (FFPE) tumor specimens stained with the Negative Control Reagent (NCR) from PD-L1 IHC 22C3 pharmDx. |