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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 HBsAg Confirmatory Test
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS, INC.
9115 HAGUE ROAD
INDIANAPOLIS, IN 46038
PMA NumberP160019
Supplement NumberS012
Date Received08/02/2021
Decision Date12/09/2021
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 to change the serum source for the control and confirmatory reagents from human to sheep for the Elecsys HBsAg Confirmatory Test.
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