|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.|
|Trade Name||AUTODELFIA HAFP KIT|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the production site or the two antibodies used in the autodelia hafp kit to wallac oy, turk, finland, and for a change in the antigen source in the hafp standards of the autodelia hafp kit.