PMA P030052S007
- Device
- UROVYSION BLADDER CANCER KIT ASSAY
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S007
- Product code
- NSD
- Decision date
- 2011-06-01
- 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 PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, A NEW SONICATION EQUIPMENT, A NEW AMINATION/LABELING PROCEDURE, AND A SUPPLEMENTAL DNA PURIFICATION PROCESSING STEP TO REDUCE RNA CARRY-OVER.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT ASSAY
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S007
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2011-06-01
- Decision code
- OK30
- Date received
- 2011-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, A NEW SONICATION EQUIPMENT, A NEW AMINATION/LABELING PROCEDURE, AND A SUPPLEMENTAL DNA PURIFICATION PROCESSING STEP TO REDUCE RNA CARRY-OVER.