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 labeling modifications that clarifies the meaning of the final interpretation repeat reactive, nonconforming for hbsag in the axsym hbsag confirmatory package insert. Also, changes to the axsym hbsag package insert to align with the removal of the term "repeat reactive" from the interpretation of results for the axsym hbsag confirmatory assays.
| Device | ABBOTT AXSYM HBSAG |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2007-12-13 |
| Decision Date | 2007-12-19 |
| PMA | P050049 |
| Supplement | S002 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap8-1 abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050049 | Original Filing | |
| S011 | 2012-11-13 | 30-day Notice |
| S010 | 2012-02-06 | 30-day Notice |
| S009 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S008 | 2011-08-01 | 135 Review Track For 30-day Notice |
| S007 | 2011-06-10 | 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 | 2008-10-24 | Real-time Process |
| S002 | 2007-12-13 | Special (immediate Track) |
| S001 | 2007-01-17 | 30-day Notice |