|Trade Name||IMMULITE AFP ASSAY|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for eliminating the test redundancy by using only the biorad lyphocheck immunoassay plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of immulite afp, free psa, and psa/3rd generation psa assay performance.