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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameTANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecarcinoembryonic antigen test system
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP840019
Supplement NumberS012
Date Received09/21/1995
Decision Date03/07/1996
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the hybritech tandem-e cea assay whith enhancements in the formualtion of the alkaline phosphatase-labeled anti-cea antibody conjugate and the addtion of the blocking reagent poly mak 33, a copolymer of intact and fab fragmented mouse anti-human ck-mm antibodies.
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