PMA P940035S014
- Device
- MATRITECH NMP22(TM) TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S014
- Product code
- NAH
- Decision date
- 2017-02-27
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- New vendor for the resin contained in the nitrocellulose membrane, and extend expiry of the antigen and purified antibodies used in the test.
Current openFDA PMA Record#
- Device
- MATRITECH NMP22(TM) TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S014
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2017-02-27
- Decision code
- OK30
- Date received
- 2017-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New vendor for the resin contained in the nitrocellulose membrane, and extend expiry of the antigen and purified antibodies used in the test.