| 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 | ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT |
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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
100 ABBOTT PARK RD.
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064 |
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| PMA Number | P060007 |
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| Date Received | 02/24/2006 |
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| Decision Date | 09/07/2006 |
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Withdrawal Date
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01/09/2014 |
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| Product Code |
LOM |
| Docket Number | 07M-0152 |
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| Notice Date | 04/29/2007 |
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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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Approval Order Statement
APPROVAL FOR THE ARCHITECT HBSAG REAGENTS, ARCHITECT HBSAG CALIBRATORS, ARCHITECT HBSAG CONTROLS, ARCHITECT HBSAG CONFIRMATORY REAGENTS, AND ARCHITECT HBSAG CONFIRMATORY MANUAL DILUENT. THE ARCHITECT HBSAG ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA). THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT FEMALES TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. THE ARCHITECT HBSAG CALIBRATORS ARE USED FOR CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) USING THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY REAGENT KITS. THE PERFORMANCE OF THE ARCHITECT HBSAG CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAYS. (CONTINUED...) |
| 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
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023
S024 S025 S026 S027 |
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