PMA P030052S008
- Device
- URO VYSION BLADDER CANCER KIT ASSAY
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S008
- Product code
- NSD
- Decision date
- 2011-07-20
- Classification
- 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
- 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.
Current openFDA PMA Record#
- Device
- URO VYSION BLADDER CANCER KIT ASSAY
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S008
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2011-07-20
- Decision code
- OK30
- Date received
- 2011-06-23
- Supplement type
- 30-Day Notice
- 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.