|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||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in a raw material used in the manufacture of the enhancement solution auxiliary reagent used with the autodelfia hafp kit.