- Device
- VENTANA MMR RxDx Panel Solid Tumors with dMMR status)
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S009
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2023-08-29
- Decision code
- OK30
- Date received
- 2023-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two contract manufacturers as approved suppliers of parts/components.