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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 HBSAGII ASSAY
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Corp.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP110041
Supplement NumberS001
Date Received10/02/2014
Decision Date02/02/2015
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  
VAPPROVAL FOR AN ADDITIONAL SURFACTANT TO THE LITE REAGENT.APPROVAL FOR AN ADDITIONAL SURFACTANT TO THE LITE REAGENT.
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