This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Addition of a variation test for materials used in the manufacture of kit reagents.
| Device | Parvovirus B19 IgM Enzyme Immunoassay |
| Classification Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| Generic Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| Applicant | DIASORIN |
| Date Received | 2017-02-08 |
| Decision Date | 2017-03-09 |
| PMA | P970055 |
| Supplement | S015 |
| Product Code | MYM |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN 1951 Northwestern Avenue stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970055 | Original Filing | |
| S022 | 2021-11-23 | 30-day Notice |
| S021 | 2020-07-16 | 30-day Notice |
| S020 | 2020-03-30 | 30-day Notice |
| S019 | 2019-03-22 | 30-day Notice |
| S018 | ||
| S017 | 2018-08-08 | Normal 180 Day Track No User Fee |
| S016 | ||
| S015 | 2017-02-08 | 30-day Notice |
| S014 | 2016-12-22 | 30-day Notice |
| S013 | 2013-11-27 | 30-day Notice |
| S012 | 2011-12-06 | 30-day Notice |
| S011 | 2011-07-06 | 30-day Notice |
| S010 | 2011-06-24 | Normal 180 Day Track No User Fee |
| S009 | 2010-05-14 | 30-day Notice |
| S008 | 2010-02-17 | 30-day Notice |
| S007 | 2009-02-09 | 30-day Notice |
| S006 | 2007-07-31 | 30-day Notice |
| S005 | 2007-06-01 | 135 Review Track For 30-day Notice |
| S004 | 2007-05-14 | 30-day Notice |
| S003 | ||
| S002 | 2005-03-23 | 30-day Notice |
| S001 | 2002-11-15 | Special (immediate Track) |