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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, PreciControl Anti-HBs and Anti-HBs CalCheck
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP010054
Supplement NumberS034
Date Received02/01/2018
Decision Date05/17/2018
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
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 change of the proprietary names of Elecsys Anti-HBs Immunoassay, Elecsys PreciControl Anti-HBs, and Elecsys Anti-HBs CalCheck to Elecsys Anti-HBs, PreciControl Anti-HBs, and Anti-HBs CalCheck.
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