|Trade Name||AXSYM AFP (LN 7A48)|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Generic Name||afp-eia diagnostic kit|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.