PMA P160046S019
- Device
- VENTANA PD-L1 (SP263) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160046
- Supplement
- S019
- Product code
- PLS
- Decision date
- 2024-10-23
- Classification
- Pathology
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Approval for the migration of the VENTANA PD-L1 (SP263) Assay from BenchMark ULTRA to BenchMark ULTRA PLUS instrument
Current openFDA PMA Record#
- Device
- VENTANA PD-L1 (SP263) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160046
- Supplement
- S019
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2024-10-23
- Decision code
- APPR
- Date received
- 2023-12-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the VENTANA PD-L1 (SP263) Assay from BenchMark ULTRA to BenchMark ULTRA PLUS instrument