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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
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 NumberS011
Date Received08/29/2011
Decision Date11/17/2011
Withdrawal Date 05/05/2021
Product Code LOM 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
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