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-corek plus assay. The device is indicated for: eti-ab-corek plus is ian in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum or plasma (edta, citrate or heparin). The eti-ab-corek plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of total anti-hbc is indicative of a laboratory diagnosis for exposure to hepatitis b virus (hbv) infection. Further hbv serological marker testing is required to define the specific disease state. The eti-ab-corek plus assay's performance has not been established for the monitoring of hbv disease or therapy.
| Device | DIASORIN ETI-AB-COREK PLUS ASSAY |
| Applicant | DIASORIN, INC. |
| Date Received | 1999-07-02 |
| Decision Date | 2001-03-30 |
| Notice Date | 2001-10-09 |
| PMA | P990045 |
| Supplement | S |
| Docket Number | 01M-0456 |
| 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 |
|---|---|---|
| P990045 | Original Filing | |
| S029 | 2021-11-23 | 30-day Notice |
| S028 | 2020-07-16 | 30-day Notice |
| S027 | 2019-08-28 | 30-day Notice |
| S026 | 2019-06-18 | 30-day Notice |
| S025 | 2018-05-30 | 30-day Notice |
| S024 | 2018-03-30 | 30-day Notice |
| S023 | ||
| S022 | 2018-02-14 | 30-day Notice |
| S021 | 2017-09-18 | 30-day Notice |
| S020 | 2017-04-25 | 30-day Notice |
| S019 | 2017-03-29 | 30-day Notice |
| S018 | 2016-05-10 | 30-day Notice |
| S017 | 2014-06-05 | 30-day Notice |
| S016 | 2013-12-27 | 30-day Notice |
| S015 | 2013-06-05 | 30-day Notice |
| S014 | 2012-11-09 | Special (immediate Track) |
| S013 | ||
| S012 | 2012-02-17 | 30-day Notice |
| S011 | 2011-10-18 | 30-day Notice |
| S010 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S009 | 2009-11-13 | Real-time Process |
| S008 | 2005-08-03 | 30-day Notice |
| S007 | ||
| S006 | 2004-04-05 | 30-day Notice |
| S005 | 2003-10-20 | Real-time Process |
| S004 | 2003-04-07 | Normal 180 Day Track No User Fee |
| S003 | 2002-10-17 | 30-day Notice |
| S002 | 2002-01-18 | Normal 180 Day Track |
| S001 |