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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.
 
DeviceElecsys Anti-HBs II, PreciControl Anti-HBs
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP190034
Supplement NumberS007
Date Received02/05/2024
Decision Date07/23/2024
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 the migration of the Elecys Anti-HBs II from cobas e 601 analyzer to the cobas e 402 analyzer.
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