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 | AXSYM CORE 2.0 |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064 |
PMA Number | P060012 |
Supplement Number | S003 |
Date Received | 09/21/2010 |
Decision Date | 10/20/2010 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE MANUFACTURING PROCESS AND QUALITY CONTROL TEST METHOD FOR THE HBCAG SOLUTIO NAND THE CHANGE TO THE MANUFACTURING PROCESS FOR THE QUALIFIED RHBCAG USED IN THE AXSYM CORE 2.0 ASSAY. |
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