PMA P100027S032
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S032
- Product code
- NYQ
- Decision date
- 2020-03-31
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- Approval for minor software changes.
Current openFDA PMA Record#
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S032
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2020-03-31
- Decision code
- APPR
- Date received
- 2020-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software changes.