|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,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 for the addition of a quality control test for protein purity of incoming raw material (albumin bovine 30% solution with 0. 1% sodium azide (bovine albumin solution) used in the manufacturing of controls and calibrators for the architect afp assay. Due to the raw material distributor not having a validated quality control test for protein purity, the additional quality control test will be implemented to ensure the protein purity of the raw material meets the manufacturers specifications.