|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||AUOTDELFIA HAFP KIT|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change of the dispensing line used in the manufacturing of the calibrators for the autodelfia and delfia xpress hafp kits and the buffer solution for the delfia xpress hafp kit.