Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
The Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 (product code PLS) is a Class 3 in vitro diagnostic device using a qualitative immunohistochemical antibody to identify PD-L1 protein expression in human clinical tissue specimens. Class 3 devices require Premarket Approval (PMA). The assay aids in identifying patients eligible for treatment with specific FDA-approved therapeutic drugs or in assessing PD-L1 expression levels in patients who may respond particularly well to such therapies. No regulation number is assigned.
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Basic Information
- Product Code
- PLS
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- PA
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.