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 HBSAG |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD DEPT 9VA- AP8-1 ABBOTT PARK, IL 60064 |
PMA Number | P050049 |
Supplement Number | S002 |
Date Received | 12/13/2007 |
Decision Date | 12/19/2007 |
Withdrawal Date
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11/15/2013 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement 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. |
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