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-ebk plus assay. The device is indicated for: eti-ab-ebk plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative detection of total antibodies to hepatitis b e antigen (anti-hbe) in human serum or plasma (edta, citrate or heparin). The eti-ab-ebk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of anti-hbe is indicative of laboratory diagnosis for seroconversion and progression to hepatitis b virus (hbv) clearance. A reactive test is presumptive laboratory evidence of hbv seroconversion. Further hbv serological marker testing is required to define the specific disease state. The anti-hbe assay's performance has not been established for the monitoring of hbv disease or therapy.
| Device | DIASORIN ETI-AB-EBK PLUS ASSAY |
| Applicant | DIASORIN, INC. |
| Date Received | 1999-07-02 |
| Decision Date | 2001-03-30 |
| Notice Date | 2001-10-09 |
| PMA | P990041 |
| Supplement | S |
| Docket Number | 01M-0452 |
| 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 |
|---|---|---|
| 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 |