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 the modification to the assay cutoff from 15 miu/ml to 10 miu/ml.
| Device | ETI-AB-AUK PLUS ASSAY |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DIASORIN, INC. |
| Date Received | 2001-09-07 |
| Decision Date | 2002-02-04 |
| PMA | P990042 |
| Supplement | S001 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990042 | Original Filing | |
| S028 | 2021-11-23 | 30-day Notice |
| S027 | 2020-07-16 | 30-day Notice |
| S026 | 2019-08-28 | 30-day Notice |
| S025 | 2019-06-18 | 30-day Notice |
| S024 | 2018-05-30 | 30-day Notice |
| S023 | 2018-03-30 | 30-day Notice |
| S022 | ||
| S021 | 2018-02-14 | 30-day Notice |
| S020 | 2017-09-18 | 30-day Notice |
| S019 | 2017-04-25 | 30-day Notice |
| S018 | 2017-03-29 | 30-day Notice |
| S017 | 2016-05-10 | 30-day Notice |
| S016 | 2014-06-05 | 30-day Notice |
| S015 | 2013-12-27 | 30-day Notice |
| S014 | 2013-06-05 | 30-day Notice |
| S013 | 2012-11-09 | Special (immediate Track) |
| S012 | ||
| S011 | 2012-02-17 | 30-day Notice |
| S010 | 2011-10-18 | 30-day Notice |
| S009 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S008 | 2008-12-22 | Normal 180 Day Track |
| S007 | 2004-04-05 | 30-day Notice |
| S006 | 2003-04-07 | Normal 180 Day Track No User Fee |
| S005 | 2002-10-30 | 30-day Notice |
| S004 | 2002-07-10 | Normal 180 Day Track |
| S003 | 2002-04-04 | Normal 180 Day Track |
| S002 | 2002-01-24 | Normal 180 Day Track |
| S001 | 2001-09-07 | Normal 180 Day Track |