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 use of a diasorin hbsag confirmatory reagent to confirm eti-mak-2 plus repeatedly reactive samples, and use of a diasorin confirmatory reagent specifically in prenatal screening to confirm all eti-mak-2 plus repeatedly reactive samples in the absence of other hbv marker testing. The device, as modified, will be marketed under the trade name diasorin hbsag confirmatory test and is indicated for an in vitro neutralization assay for qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma samples (edta, heparin, and citrate) found to be repeatedly reactive for hbsag by eti-mak-2 plus. This assay has not been fda-approved for the screening of blood or plasma donors.
| Device | DIASORIN HBSAG CONFIRMATORY TEST |
| 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 | 2002-10-29 |
| Decision Date | 2003-03-14 |
| PMA | P990038 |
| Supplement | S004 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|---|---|
| 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 |