|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 KIT|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Generic Name||kit, test, alpha-fetoprotein for neural tube defects|
|Supplement Type||special (immediate track)|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to the patient and physician brochures and 3 versions of the package insert for the laboratory.