|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||ARCHITECT AFP ASSAY|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for migration of architect afp assay to the architect i system family member, the architect il000sr.