PMA P100027S004
- Device
- INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S004
- Product code
- NYQ
- Decision date
- 2012-11-21
- 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 THE CHANGE OF THE TWO LITER (2L) BOTTLES FOR EACH OF THE AQUEOUS-BASED REAGENTS FROM FLUORINATED TO NON-FLUORINATED BOTTLES.
Current openFDA PMA Record#
- Device
- INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S004
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2012-11-21
- Decision code
- APPR
- Date received
- 2012-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CHANGE OF THE TWO LITER (2L) BOTTLES FOR EACH OF THE AQUEOUS-BASED REAGENTS FROM FLUORINATED TO NON-FLUORINATED BOTTLES.