|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 TEST SYSTEM|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Second alternative type of topo (trioctylphosphine oxide) raw material type used in the manufacturing of the enhancement solution for the device.