| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | ABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
DEPT 9VA- AP8-1
ABBOTT PARK, IL 60064 |
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| PMA Number | P050049 |
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| Date Received | 12/06/2005 |
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| Decision Date | 06/01/2006 |
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Withdrawal Date
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11/15/2013 |
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| Product Code |
LOM |
| Docket Number | 07M-0174 |
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| Notice Date | 05/03/2007 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE ABBOTT AXSYM HBSAG ASSAY, WHICH IS INDICATED FOR: AXSYM HBSAG: AXSYM HBSAG IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE ASSAY MAY BE USED TO TEST FOR HBV INFECTION IN PREGNANT WOMEN. AXSYM HBSAG CONFIRMATORY: AXSYM HBSAG CONFIRMATORY IN S MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED FOR CONFIRMATION OF SAMPLES FOUND TO BE REPEATEDLY REACTIVE BY THE AXSYM HBSAG ASSAY. THE ASSAY MAY BE USED TO CONFIRM HEPATITIS B VIRUS (HBV) INFECTION IN PREGNANT WOMAN. AXSYM HBSAG CONTROLS: THE AXSYM HBSAG POSITIVE AND NEGATIVE CONTROLS ARE FOR USE IN MONITORING THE PERFORMANCE OF THE AXSYM HBSAG REAGENT KIT AND THE AXSYM HBSAG CONFIRMATORY KIT. THE PERFORMANCE OF THE AXSYM HBSAG CONTROLS HAVE NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAYS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
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