- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S003
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2022-06-10
- Decision code
- APPR
- Date received
- 2022-01-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of two new contract manufacturers as approved suppliers for component parts.