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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-HCV II
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantRoche Diagnostics Operations, Inc.
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP140021
Supplement NumberS014
Date Received04/17/2018
Decision Date06/13/2018
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series
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