- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S039
- Product code
- NYQ
- Generic name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Decision date
- 2023-08-29
- Decision code
- OK30
- Date received
- 2023-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two contract manufacturers as approved suppliers of parts/components.