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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 Anti-HBe2 (AHBe2) Assay
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP200017
Supplement NumberS001
Date Received08/10/2021
Decision Date01/06/2022
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for migration of the ADVIA Centaur Anti-HBe2 (aHBe2) assay to the Atellica IM analyzer. The device, as modified, will be marketed under the trade name Atellica IM Anti-HBe2 (aHBe2).
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