|Trade Name||ABBOTT ARCHITECT 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||normal 180 day track no user fee|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for manufacturing site located at abbott ireland diagsnostics division in sligo, ireland.