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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP030049
Supplement NumberS004
Date Received03/09/2009
Decision Date04/09/2009
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICES ADVIA CENTAUR HBSAG AND ADVIA HBSAG CONFIRMATORY ASSAY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBSAG READYPACKREAGENTS. ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY AND ADVIA CENTAUR HBSAGQUALITY CONTROL MATERIAL ARE INDICATED FOR:ADVIA CENTAUR HBSAG READYPACK REAGENTSTHE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTION.THIS PRODUCT IS NOT FOR USE FOR TESTING OR SCREENING POOLED SAMPLES CONTAINING SPECIMENS FROM MORE THAN ONE INDIVIDUAL, OR OTHERWISE IN BLOOD OR PLASMA SCREENING.ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY:THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAYFOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA. LITHIUM OR SODIUM HEPARIN) USING THEADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OF HBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIACENTAUR ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL:FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS WHEN USING SERUM.
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