|Trade Name||DIMENSION FPSA FLEX REAGENT CARTRIDGE|
|Classification Name||test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions|
|Generic Name||prostate specific antigen (psa) for detection and management of prostate cancers|
|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.