|Trade Name||AXSYM TOTAL PSA (LN 3C19)|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||immunochemistry analyzer|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.