This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the diasorin eti-ab-auk plus assay. The device is indicated for: eti-ab-auk plus is an in vitro enzyme immunoassay (eia) intended for the qualitative detection of antibodies to hepatitis b surface antigen (anti-hbs) in human erum or plasma (edta, citrate or heparin). The eti-ab-auk plus is intended for manual use only. The detection of anti-hbs is indicative of laboratory diagnosis for seroconversion from hepatitis b virus (hbv) infection. Anti-hbs is also used to assess laboratory diagnosis of past exposure to hepatitis b in potential hepatitis b vaccine recipients and to determine the presence os an immune response in vaccine recipients. The anti-hbs assay's performance has not been established for the monitoring of hvb disease or therapy.
| Device | DIASORIN ETI-AB-AUK 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 | 1999-07-02 |
| Decision Date | 2001-03-30 |
| Notice Date | 2001-10-09 |
| PMA | P990042 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 01M-0453 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |