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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/Confirmatory Readypack Reagents and QC Material
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 NumberS010
Date Received07/31/2020
Decision Date08/25/2020
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Procedure for testing raw materials, in-process and final products.
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