Note: 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. |
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Device | ABBOTT AXSYM AUSAB |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD DEPT 9VA- AP5-2 ABBOTT PARK, IL 60064 |
PMA Number | P060003 |
Supplement Number | S001 |
Date Received | 08/15/2006 |
Decision Date | 09/11/2006 |
Withdrawal Date
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11/15/2013 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF ADDITIONAL TESTING AT TWO DIFFERENT STAGES IN THE MANUFACTURING PROCESS. |
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