|Trade Name||DIMENSION FPSA FLEX REAGENT|
|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|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes to the product instructions for use: 1) add a new section titled risk and safety to provide additional safety information about the preservatives present in some of the product reagents; 2) add information under the section titled precautions on the presence of sodium azide, along with hazard and disposal information; and 3) provide for reference only additional ufu changes being implemented concurrently with the safety information.