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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 (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control
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 NumberS004
Date Received07/24/2017
Decision Date04/19/2018
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for migration of the ADVIA Centaur HBsAgII (HBsII), the ADVIA Centaur HBsAg Confirmatory, and the ADVIA Centaur HBsAg Quality Control Material onto the Atellica IM analyzer.
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