|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||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes that add precaution and an instruction that is intended to enhance the safe use of herceptest.