PMA P230016S005
- Device
- MAGE-A4 IHC 1F9 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P230016
- Supplement
- S005
- Product code
- SBL
- Decision date
- 2026-09-11
- Classification
- Pathology
- Generic name
- Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
- Approval order statement
- approval of manufacturing process and equipment changes for filling and capping
Current openFDA PMA Record#
- Device
- MAGE-A4 IHC 1F9 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P230016
- Supplement
- S005
- Product code
- SBL
- Generic name
- Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
- Decision date
- 2026-09-11
- Decision code
- OK30
- Date received
- 2026-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of manufacturing process and equipment changes for filling and capping