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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 and PreciControl HBeAg
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
9115 HAGUE RD
INDIANAPOLIS, IN 46250
PMA NumberP130015
Supplement NumberS013
Date Received09/15/2017
Decision Date03/02/2018
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the migration of claims from the FDA approved Elecsys HBeAg assay and PreciControl HBeAg on the MODULAR ANALYTICS E170 immunoassay analyzer to the cobas e 801 immunoassay analyzer.
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