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.
Approval for a change in the sample stability claim for 48 hours at 2-8 degrees c to8 days at 2-8 degrees c and modifications of the labeling to reflect the change.
| Device | ETI-CORE-IGMK PLUS ASSAY |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DIASORIN, INC. |
| Date Received | 2009-11-13 |
| Decision Date | 2010-01-12 |
| PMA | P990044 |
| Supplement | S009 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990044 | Original Filing | |
| S029 | 2021-11-23 | 30-day Notice |
| S028 | 2020-07-16 | 30-day Notice |
| S027 | 2019-08-28 | 30-day Notice |
| S026 | 2019-06-18 | 30-day Notice |
| S025 | 2018-05-30 | 30-day Notice |
| S024 | 2018-03-30 | 30-day Notice |
| S023 | ||
| S022 | 2018-02-14 | 30-day Notice |
| S021 | 2017-09-18 | 30-day Notice |
| S020 | 2017-04-25 | 30-day Notice |
| S019 | 2017-03-29 | 30-day Notice |
| S018 | 2016-05-10 | 30-day Notice |
| S017 | 2014-06-05 | 30-day Notice |
| S016 | 2013-12-27 | 30-day Notice |
| S015 | 2013-06-05 | 30-day Notice |
| S014 | 2012-11-09 | Special (immediate Track) |
| S013 | ||
| S012 | 2012-02-17 | 30-day Notice |
| S011 | 2011-10-18 | 30-day Notice |
| S010 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S009 | 2009-11-13 | Real-time Process |
| S008 | 2006-12-29 | 30-day Notice |
| S007 | 2005-06-03 | 30-day Notice |
| S006 | ||
| S005 | 2004-04-05 | 30-day Notice |
| S004 | 2003-04-14 | 30-day Notice |
| S003 | 2003-04-09 | Normal 180 Day Track No User Fee |
| S002 | 2002-10-17 | 30-day Notice |
| S001 | 2002-01-07 | Normal 180 Day Track |