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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-HBC IGM ASSAY (COBAS E 411 ANALYZER)
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague road
p.o. box 50416
indianapolis, IN 46250-0457
PMA NumberP110031
Supplement NumberS010
Date Received07/19/2013
Decision Date08/06/2013
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR IN-PROCESS TESTING OF A BULK REAGENT.
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