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.
Changes to replace reagents for in- process testing of the hbv core antigen (anti-hbc) specific activity and to allow the use of two alternative precursors for manufacturing of the purified filtered hbc igg within the abbott park, illinois manufacturing facility.
| Device | AXSYM CORE-M 2.0 |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2011-03-07 |
| Decision Date | 2011-04-04 |
| PMA | P060009 |
| Supplement | S005 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 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 dept: 09vb Bldg: Ap5-2 abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060009 | Original Filing | |
| S007 | 2012-11-13 | 30-day Notice |
| S006 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S005 | 2011-03-07 | 30-day Notice |
| S004 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S003 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S002 | 2010-09-27 | 30-day Notice |
| S001 | 2007-01-17 | 30-day Notice |