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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 IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE ROAD
P.O. BOX 50416
INDIANAPOLIS, IN 46250-0457
PMA NumberP990012
Supplement NumberS026
Date Received02/16/2016
Decision Date03/16/2016
Withdrawal Date 05/05/2021
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
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