PMA P230018S001
- Device
- VENTANA CLDN18 (43-14A) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P230018
- Supplement
- S001
- Product code
- QZJ
- Decision date
- 2025-06-20
- Classification
- Pathology
- Generic name
- Immunohistochemistry assay, antibody, claudin 18
- Approval order statement
- qualification of an alternate supplier for assay kit component
Current openFDA PMA Record#
- Device
- VENTANA CLDN18 (43-14A) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P230018
- Supplement
- S001
- Product code
- QZJ
- Generic name
- Immunohistochemistry assay, antibody, claudin 18
- 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