|Trade Name||INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|
|Classification Name||chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|
|Applicant||VENTANA MEDICAL SYSTEMS, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Qualification of a new supplier for a raw material that is used in the manufacture of the detection kit associated with the inform her-2 dual ish dna probe cocktail. As part of this change in raw material, a change in the cell media used to grow the anti-dnp antibody is also being implemented.