PMA P200019S010
- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems
- PMA number
- P200019
- Supplement
- S010
- Product code
- QNH
- Decision date
- 2024-12-20
- Classification
- Pathology
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Approval order statement
- Approval for assay migration of VENTANA MMR RxDx Panel from the BenchMark ULTRA platform to BenchMark ULTRA PLUS platform.
Current openFDA PMA Record#
- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems
- PMA number
- P200019
- Supplement
- S010
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2024-12-20
- Decision code
- APPR
- Date received
- 2023-12-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for assay migration of VENTANA MMR RxDx Panel from the BenchMark ULTRA platform to BenchMark ULTRA PLUS platform.