PMA P100027S031
- Device
- Inform HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S031
- Product code
- NYQ
- Decision date
- 2019-11-19
- Classification
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- Approval for minor software and firmware updates for Ventana System Software on the BenchMark ULTRA instruments.
Current openFDA PMA Record#
- Device
- Inform HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S031
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2019-11-19
- Decision code
- APPR
- Date received
- 2019-08-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software and firmware updates for Ventana System Software on the BenchMark ULTRA instruments.