|Trade Name||DIMENSION TPSA FLEX REAGENT CARTRIDGE|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the flex? assembly machine production line number 4 to allow production of the loci chemistries on this production line.