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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPUS(R) CEA TEST SYSTEM
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecea assay
Regulation Number866.6010
ApplicantBEHRING DIAGNOSTICS, INC.
PMA NumberP920021
Supplement NumberS001
Date Received07/03/1995
Decision Date02/23/1996
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the cea test system to the opus plus and opus magnum analyzers. The same test system is used on all three instruments.
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