PMA P100027S013
- Device
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S013
- Product code
- NYQ
- Decision date
- 2013-12-16
- 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
- ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
Current openFDA PMA Record#
- Device
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S013
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2013-12-16
- Decision code
- OK30
- Date received
- 2013-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.