PMA P940035S015
- Device
- Alere NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S015
- Product code
- NAH
- Decision date
- 2018-05-17
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- Change in the manufacturing process of the Alere NMP22® BladderChek® Test, in which standard parameter adjustments are needed in the manufacture of the stock conjugate due to the biological nature of the antibodies used
Current openFDA PMA Record#
- Device
- Alere NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S015
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2018-05-17
- Decision code
- OK30
- Date received
- 2018-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the manufacturing process of the Alere NMP22® BladderChek® Test, in which standard parameter adjustments are needed in the manufacture of the stock conjugate due to the biological nature of the antibodies used