PMA P220006S006
- Device
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P220006
- Supplement
- S006
- Product code
- QUL
- Decision date
- 2025-01-08
- Classification
- Medical Genetics
- Generic name
- Immunohistochemistry Assay, Antibody, FOLR1
- Approval order statement
- Approval to update the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay labeling to improve the recommendations for tissue fixation.
Current openFDA PMA Record#
- Device
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P220006
- Supplement
- S006
- Product code
- QUL
- Generic name
- Immunohistochemistry Assay, Antibody, FOLR1
- Decision date
- 2025-01-08
- Decision code
- APPR
- Date received
- 2024-09-13
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to update the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay labeling to improve the recommendations for tissue fixation.