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Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA product code PLS · Class 3 · Unknown

5
Registered devices
35
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

PD-L1 IHC 22C3 pharmDx — AGILENT TECHNOLOGIES, INC.VENTANA PD-L1 (SP263) Assay — Ventana Medical Systems, Inc.PD-L1 IHC 28-8 pharmDx — AGILENT TECHNOLOGIES, INC.VENTANA PDL1 SP142 ASSAY — Ventana Medical Systems, Inc.PD-L1 IHC 22C3 pharmDx — AGILENT TECHNOLOGIES, INC.

Recent recalls

DateFirmReason
2022-11-18Ventana Medical Systems, Inc.Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause
2018-02-02Dako North America Inc.To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six mon

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.