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 quality control test of an incoming raw material used in the preparation of coated strips of the eti-ab-ebk plus which is an in vitro enzyme immunoassay intended for use in the qualitative determination of total antibodies to hepatitis b e antigen in human serum or plasma.
| Device | DIASORIN ETI-AB-EBK PLUS |
| 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 | 2004-03-11 |
| Decision Date | 2004-03-26 |
| PMA | P990041 |
| Supplement | S005 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| 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 |