Product code NAH
- Device name
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P940035S017 | NMP22 BladderChek Test | Abbott Diagnostics Scarborough, Inc. | 2022-07-12 |
| P940035S016 | Alere NMP22 BladderChek Test | Abbott Diagnostics Scarborough, Inc. | 2021-06-15 |
| P030052S026 | UroVysion Bladder Cancer Kit | Abbott Molecular | 2019-08-26 |
| P030052S023 | UroVysion Bladder Cancer Kit | Abbott Molecular | 2018-07-11 |
| P940035S015 | Alere NMP22 BladderChek Test | Abbott Diagnostics Scarborough, Inc. | 2018-05-17 |
| P030052S021 | UroVysion Bladder Cancer Kit | Abbott Molecular | 2017-12-06 |
| P940035S014 | MATRITECH NMP22(TM) TEST KIT | Abbott Diagnostics Scarborough, Inc. | 2017-02-27 |
| P940035S013 | Alere NMP22 BladderChek Test | Abbott Diagnostics Scarborough, Inc. | 2016-09-08 |
| P940035S012 | ALERE NMP22(TM) TEST | Abbott Diagnostics Scarborough, Inc. | 2016-05-06 |
| P940035S011 | ALERE NMP22 BLADDERCHEK TEST | Abbott Diagnostics Scarborough, Inc. | 2015-07-28 |
| P940035S010 | ALERE NMP22 TEST | Abbott Diagnostics Scarborough, Inc. | 2013-07-16 |
| P940035S009 | NMP22 BLADDERCHEK TEST | Abbott Diagnostics Scarborough, Inc. | 2013-04-02 |
| P940035S008 | ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT | Abbott Diagnostics Scarborough, Inc. | 2012-03-21 |
| P940035S007 | ALERE NMP22 URINE COLLECTION KIT | Abbott Diagnostics Scarborough, Inc. | 2012-01-20 |
| P940035S006 | NMP22 BLADDERCHEK TEST KIT | Abbott Diagnostics Scarborough, Inc. | 2011-11-15 |
| P940035S005 | NMP22 ELISA TEST KIT | Abbott Diagnostics Scarborough, Inc. | 2008-06-03 |
| P940035S004 | NMP22 BLADDERCHEK TEST KIT | Abbott Diagnostics Scarborough, Inc. | 2008-05-20 |
| P940035S003 | NMP22 BLADDERCHEK TEST KIT | Abbott Diagnostics Scarborough, Inc. | 2003-04-25 |
| P940035S002 | MATRITECH NMP22 TEST KIT | Abbott Diagnostics Scarborough, Inc. | 2000-01-18 |
| P940035 | NMP22 BladderChek Test | Abbott Diagnostics Scarborough, Inc. | 1996-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811877011538 | NMP22 BladderChek Test | Alere Scarborough, Inc. | 2022-08-08 |
| 06009544019497 | N/A | SOUTHERN IMPLANTS (PTY) LTD | 2022-03-19 |
| 00859598007041 | Contour Healer | CONTOUR HEALER, LLC | 2018-09-07 |
| 00859598007119 | Contour Healer | CONTOUR HEALER, LLC | 2018-09-07 |
| 00859598007126 | Contour Healer | CONTOUR HEALER, LLC | 2018-09-07 |
| 10811877010545 | Alere NMP22 Test | Alere Scarborough, Inc. | 2014-09-01 |
| 10811877010637 | Alere NMP22® Urine Collection Kit | Alere Scarborough, Inc. | 2014-09-01 |
| 10811877010774 | Alere NMP22 BladderChek Test | Alere Scarborough, Inc. | 2014-09-01 |
| 10811877010569 | Alere NMP22 BladderChek Test | Alere Scarborough, Inc. | 2014-09-01 |