PLS — Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Class III
FDA product code PLS covers "Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PLS
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
Definition
The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.