|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||URO VYSION BLADDER CANCER KIT ASSAY|
|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||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of an in-process validated test method for restriction enzyme digest gel electrophoresis (dna restriction analysis), change in digest restriction enzymes used in the in-process test, implementation of an in-process validated test method for dna concentration determination by uv/vis absorbance spectrophotometry, and addition of an incoming screening test for dextran sulfate.