Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | URO VYSION BLADDER CANCER KIT ASSAY |
Generic Name | Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence |
Applicant | ABBOTT MOLECULAR 1300 E. Touhy Avenue Des Plaines, IL 60018 |
PMA Number | P030052 |
Supplement Number | S008 |
Date Received | 06/23/2011 |
Decision Date | 07/20/2011 |
Product Code |
NSD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | 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. |
|
|