|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||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the thermobrite automated slide heating plate supplied by an alternate vendor as an optional alternative of the hybrite automated slide heating plate instrument and to add instructions for use of said thermobrite to the current urovysion bladder cancer kit package insert.