- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S016
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2026-10-08
- Decision code
- APPR
- Date received
- 2025-12-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add a new anti-PMS2 clone, VENTANA anti-PMS2 (SP487) Rabbit Monoclonal Primary Antibody, to the VENTANA MMR RxDx Panel for use on the BenchMark ULTRA and BenchMark ULTRA PLUS platforms