Product Code: PLS


Products Classified as PLS

5050Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

Total Product Life Cycle (TPLC) Devices

5050Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

Pre-market Approvals for PLS

P150027PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)DAKO NORTH AMERICA, INC.
P160046VENTANA PD-L1 (SP263) AssayVentana Medical Systems, Inc.
P160002VENTANA PD-L1(SP142) Assay.VENTANA MEDICAL SYSTEMS, INC.
P150025PD-L1 IHC 28-8 pharmDxDAKO NORTH AMERICA, INC.
P150013PD-L1 IHC 22C3 pharmDxDAKO NORTH AMERICA, INC.

Global Unique Device Identification Database

05700571108161Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
05700571107300Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
05700573003563Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
05700571112755Immunohistochemistry assay, antibody, programmed death-ligand 1
04015630972784Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Maude Adverse Events

PD-L1 SP263VENTANA MEDICAL SYSTEMS INC2017-07-14
PD-L1 IHC 22C3 PHARMDXDAKO NORTH AMERICA, INC.2017-01-11
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