PLS
- Product code
- PLS
- Device name
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
FDA classification 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.
Official FDA classification page: PLS
Classification and pathway per current FDA publications. Data from openFDA (CC0).