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.
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of hbsag positive samples.
| Device | ETI-MAK-2 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 | 2013-12-27 |
| Decision Date | 2014-01-10 |
| PMA | P990038 |
| Supplement | S019 |
| Product Code | LOM |
| 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, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990038 | Original Filing | |
| S032 | 2021-11-23 | 30-day Notice |
| S031 | 2020-07-16 | 30-day Notice |
| S030 | 2019-08-28 | 30-day Notice |
| S029 | 2019-06-18 | 30-day Notice |
| S028 | 2018-05-30 | 30-day Notice |
| S027 | 2018-03-30 | 30-day Notice |
| S026 | ||
| S025 | 2018-02-14 | 30-day Notice |
| S024 | 2017-09-18 | 30-day Notice |
| S023 | 2017-04-25 | 30-day Notice |
| S022 | 2017-03-29 | 30-day Notice |
| S021 | 2016-05-10 | 30-day Notice |
| S020 | 2014-06-05 | 30-day Notice |
| S019 | 2013-12-27 | 30-day Notice |
| S018 | 2013-06-05 | 30-day Notice |
| S017 | 2012-11-09 | Special (immediate Track) |
| S016 | ||
| S015 | 2012-02-17 | 30-day Notice |
| S014 | 2011-10-18 | 30-day Notice |
| S013 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S012 | 2009-11-13 | Real-time Process |
| S011 | 2006-03-24 | Special (immediate Track) |
| S010 | 2005-06-03 | 30-day Notice |
| S009 | ||
| S008 | 2004-04-23 | 30-day Notice |
| S007 | 2004-04-05 | 30-day Notice |
| S006 | 2004-04-05 | 30-day Notice |
| S005 | 2003-07-16 | Special (immediate Track) |
| S004 | 2002-10-29 | Normal 180 Day Track |
| S003 | 2002-10-17 | 30-day Notice |
| S002 | 2002-01-16 | Normal 180 Day Track |
| S001 |