|Trade Name||AXSYM FREE PSA (LN 3C20)|
|Classification Name||test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions|
|Generic Name||free psa|
|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.