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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCORAB
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameantibody to hepatitis b core antigen 125i (human)
PMA NumberP780016
Supplement NumberS004
Date Received01/03/1984
Decision Date10/11/1984
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No