- Device
- VENTANA HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190031
- Supplement
- S012
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2025-05-16
- Decision code
- APPR
- Date received
- 2024-09-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the VENTANA HER2 Dual ISH DNA Probe Cocktail from BenchMark ULTRA to BenchMark ULTRA PLUS instrument