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.
Manufacturing location and qc testing sequence changes for streptavidin-hrp substrate.
| Device | BIOTRIN 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 | 2011-12-06 |
| Decision Date | 2011-12-29 |
| PMA | P970055 |
| Supplement | S012 |
| 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) |