PMA P030052S009
- Device
- UROVYSION BLADDER CANCER KIT ASSAY
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S009
- Product code
- NSD
- Decision date
- 2012-08-10
- 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
- ELIMINATE A SECOND CLONE IDENTITY TESTING PROCEDURE AT THE FERMENTATION STAGE FOR LSI 9P21, QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEADMIXING SYSTEM AND VALIDATION OF MIXING PROCESS IN THE MANUFACTURE OF HYBRIDIZATION BUFFER,IMPLEMENT THE OPTICAL DENSITY READING AS AN ADDITIONAL IN PROCESS QUALITY CONTROL, VALIDATE ANEXISTING MIXING PROCESS FOR THE UROVYSION BULK SOLUTION, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT ASSAY
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S009
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2012-08-10
- Decision code
- OK30
- Date received
- 2012-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATE A SECOND CLONE IDENTITY TESTING PROCEDURE AT THE FERMENTATION STAGE FOR LSI 9P21, QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEADMIXING SYSTEM AND VALIDATION OF MIXING PROCESS IN THE MANUFACTURE OF HYBRIDIZATION BUFFER,IMPLEMENT THE OPTICAL DENSITY READING AS AN ADDITIONAL IN PROCESS QUALITY CONTROL, VALIDATE ANEXISTING MIXING PROCESS FOR THE UROVYSION BULK SOLUTION, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.