PMA P100027S019
- Device
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S019
- Product code
- NYQ
- Decision date
- 2015-02-19
- 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 ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.
Current openFDA PMA Record#
- Device
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S019
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2015-02-19
- Decision code
- APPR
- Date received
- 2014-06-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.