|Trade Name||UROVYSION BLADDER CANCER KIT|
|Classification Name||test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|
|Generic Name||test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change to the urovysion bladder cancer kit package insert to correct an inaccuracy in a labeling schematic in the urovysion package insert 30-608358 identified during a review of the package insert.