|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 (LN 3P36)|
|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 |
Change to the supplier of bovine serum albumin (bsa) for use in the manufacture of precursor components for the architect hbsag qualitative (ln 4p53), architect hbsag qualitative confirmatory (ln 4p54), and architect afp (ln 3p36) assays.