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
| Device | Alere NMP22 BladderChek Test |
| Classification Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Generic Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Applicant | ALERE SCARBOROUGH, INC |
| Date Received | 2018-04-18 |
| Decision Date | 2018-05-17 |
| PMA | P940035 |
| Supplement | S015 |
| Product Code | NAH |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALERE SCARBOROUGH, INC 10 Southgate Road scarborough, ME 04074 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940035 | | Original Filing |
| S017 |
2022-02-08 |
Normal 180 Day Track No User Fee |
| S016 |
2021-05-27 |
30-day Notice |
| S015 |
2018-04-18 |
30-day Notice |
| S014 |
2017-01-30 |
30-day Notice |
| S013 |
2016-08-16 |
30-day Notice |
| S012 |
2016-04-06 |
30-day Notice |
| S011 |
2015-07-01 |
30-day Notice |
| S010 |
2013-07-10 |
Special (immediate Track) |
| S009 |
2013-03-18 |
30-day Notice |
| S008 |
2010-11-22 |
Normal 180 Day Track No User Fee |
| S007 |
2011-07-27 |
Normal 180 Day Track No User Fee |
| S006 |
2011-05-11 |
Normal 180 Day Track No User Fee |
| S005 |
2008-05-16 |
Normal 180 Day Track No User Fee |
| S004 |
2008-03-27 |
Normal 180 Day Track No User Fee |
| S003 |
2002-09-16 |
Normal 180 Day Track |
| S002 |
1999-07-23 |
Panel Track |
| S001 |
1996-12-16 |
Normal 180 Day Track |
NIH GUDID Devices