|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||system, test, her-2/neu, ihc|
|Generic Name||system, test, her-2/neu, ihc|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing filling process to increase the reagent fill volume to address shortage concerns.