Change in the manufacturing process of the alere nmp22 test, in which the manufacture of the antigens used in the manufacture of the urine calibrators and urine controls has been outsourced to a third party vendor.
| Device | ALERE NMP22(TM) 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 | 2016-04-06 |
| Decision Date | 2016-05-06 |
| PMA | P940035 |
| Supplement | S012 |
| 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