PMA P100027S040
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S040
- Product code
- NYQ
- Decision date
- 2023-11-08
- Classification
- Pathology
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- addition of an alternative supplier for dispenser component parts
Current openFDA PMA Record#
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S040
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2023-11-08
- Decision code
- OK30
- Date received
- 2023-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternative supplier for dispenser component parts