- Device
- HercepTest™
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S026
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2026-01-28
- Decision code
- APPR
- Date received
- 2025-12-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for specific labeling change to provide clearer instructions for use, which will improve user compliance and reduce errors, thereby ensuring consistent staining results.