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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER)
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP110031
Supplement NumberS010
Date Received07/19/2013
Decision Date08/06/2013
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
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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