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Device | ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street Walpole, MA 02032 |
PMA Number | P030029 |
Date Received | 07/02/2003 |
Decision Date | 05/14/2004 |
Withdrawal Date
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05/24/2016 |
Product Code |
LOM |
Docket Number | 05M-0025 |
Notice Date | 01/21/2005 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND ADVIA CENTAUR ANTI-HBS READYPACK CALIBRATORS. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IN UNKNOWN. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013
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