PMA P210001S006
- Device
- VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S006
- Product code
- QNH
- Decision date
- 2022-07-29
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Approval order statement
- Addition of alternative suppliers for component parts.
Current openFDA PMA Record#
- Device
- VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S006
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2022-07-29
- Decision code
- OK30
- Date received
- 2022-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative suppliers for component parts.