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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-HBC IGM ON COBAS E 601
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP110022
Supplement NumberS013
Date Received10/16/2014
Decision Date11/26/2014
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Immunology
Supplement TypeReal-Time Process
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 SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
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