|Trade Name||VIDAS TOTAL PSA|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an alternate alkaline phosphatase (alp) from the same qualified supplier; it also proposed an improvement to the quality controls performed on thismaterial.