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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameTRUQUANT(R) BR(TM) RIA
Classification Nameantigen, cancer 549
Generic Nameradioimmunoassay for the measurement of ca 27.29 antigen in serum or plasma
ApplicantBIOMIRA, INC.
PMA NumberP950011
Date Received02/28/1995
Decision Date03/29/1996
Product Code
MJB
Docket Number 96M-0216
Notice Date 07/23/1996
Advisory Committee Immunology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for an in vitro diagnositc device (biomira truquant br ria).
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