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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
Generic NameSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Regulation Number866.6010
ApplicantHybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego, CA 92126
PMA NumberP840019
Supplement NumberS012
Date Received09/21/1995
Decision Date03/07/1996
Product Code DHX 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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