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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 (HBS) ASSAY
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP030049
Supplement NumberS011
Date Received07/10/2014
Decision Date10/28/2014
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF TWO WASHES OF THE ANCILLARY PROBE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP INSTRUMENTS WHEN THE ADVIA CENTAUR HBSAG ASSAY IS RUN IMMEDIATELY FOLLOWING THE ADVIA CENTAUR SYPHILIS ASSAY.
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