PMA P200019S012
- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems
- PMA number
- P200019
- Supplement
- S012
- Product code
- QNH
- Decision date
- 2025-06-20
- Classification
- Pathology
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Approval order statement
- qualification of an alternate supplier for assay kit component
Current openFDA PMA Record#
- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems
- PMA number
- P200019
- Supplement
- S012
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2025-06-20
- Decision code
- OK30
- Date received
- 2025-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of an alternate supplier for assay kit component