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.
Change in the qc test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
| Device | ETI-AB-EBK 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 | 2012-02-17 |
| Decision Date | 2012-03-09 |
| PMA | P990041 |
| Supplement | S014 |
| 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 |
|---|---|---|
| P990041 | Original Filing | |
| S031 | 2021-11-23 | 30-day Notice |
| S030 | 2020-07-16 | 30-day Notice |
| S029 | 2019-08-28 | 30-day Notice |
| S028 | 2019-06-18 | 30-day Notice |
| S027 | 2018-05-30 | 30-day Notice |
| S026 | 2018-03-30 | 30-day Notice |
| S025 | ||
| S024 | 2018-02-14 | 30-day Notice |
| S023 | 2017-09-18 | 30-day Notice |
| S022 | 2017-04-25 | 30-day Notice |
| S021 | 2017-03-29 | 30-day Notice |
| S020 | 2016-05-10 | 30-day Notice |
| S019 | 2014-06-05 | 30-day Notice |
| S018 | 2013-12-27 | 30-day Notice |
| S017 | 2013-06-05 | 30-day Notice |
| S016 | 2012-11-09 | Special (immediate Track) |
| S015 | ||
| S014 | 2012-02-17 | 30-day Notice |
| S013 | 2011-10-18 | 30-day Notice |
| S012 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S011 | 2009-11-13 | Real-time Process |
| S010 | 2009-01-29 | 30-day Notice |
| S009 | 2006-12-29 | 30-day Notice |
| S008 | 2005-06-03 | 30-day Notice |
| S007 | ||
| S006 | 2004-04-05 | 30-day Notice |
| S005 | 2004-03-11 | 30-day Notice |
| S004 | 2004-01-30 | Special (immediate Track) |
| S003 | 2003-04-18 | Normal 180 Day Track No User Fee |
| S002 | 2002-10-17 | 30-day Notice |
| S001 | 2002-01-22 | Normal 180 Day Track |