PMA P100027S026
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S026
- Product code
- NYQ
- Decision date
- 2017-03-13
- 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 software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.
Current openFDA PMA Record#
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S026
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2017-03-13
- Decision code
- APPR
- Date received
- 2016-11-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.