510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLSClass III

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Unknown
FDA source (opens on fda.gov)

PLS is the FDA product code for Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
PLS
Device name
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code