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 a change of test method with a different assay for determining antibody to hepatitis b virus core antigen specific activity and allowing for use of high titer igg in in place of each other when their concentrations overlap.
| Device | AXSYM CORE 2.0 |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2011-03-21 |
| Decision Date | 2011-04-21 |
| PMA | P060012 |
| Supplement | S007 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept. 09vb abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060012 | Original Filing | |
| S010 | 2012-11-13 | 30-day Notice |
| S009 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S008 | 2011-09-07 | Special (immediate Track) |
| S007 | 2011-03-21 | 135 Review Track For 30-day Notice |
| S006 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S005 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S004 | 2010-09-27 | 30-day Notice |
| S003 | 2010-09-21 | 30-day Notice |
| S002 | 2010-05-19 | 30-day Notice |
| S001 | 2007-01-17 | 30-day Notice |