PMA P940035S011
- Device
- ALERE NMP22 BLADDERCHEK TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S011
- Product code
- NAH
- Decision date
- 2015-07-28
- 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 HEAT TREATED NORMAL MOUSE SERUM IS USED INSTEAD OF NORMAL MOUSE SERUM AS A CONTROL TEST LINE BLOCKING AGENT.
Current openFDA PMA Record#
- Device
- ALERE NMP22 BLADDERCHEK TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S011
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2015-07-28
- Decision code
- OK30
- Date received
- 2015-07-01
- 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 HEAT TREATED NORMAL MOUSE SERUM IS USED INSTEAD OF NORMAL MOUSE SERUM AS A CONTROL TEST LINE BLOCKING AGENT.