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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 HBeAg Test System
ApplicantRoche Diagnostics Operations, Inc.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP130015
Supplement NumberS017
Date Received09/30/2022
Decision Date04/18/2023
Reclassified Date10/20/2025
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 Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to the cobas e 402 immunoassay analyzer
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