|Trade Name||AFP IMMULITE ASSAY|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The change is to implement use of a fully automated filling and packaging line for the immulite chemiluminescent substrate. The current method of filling and packaging the substrate is by use of a semi-automated line. Full automation of the line eliminates repetitive actions that are performed manually.