PMA P840019S012

Device: TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
Applicant: Hybritech, Inc.
PMA number: P840019
Supplement: S012
Product code: DHX
Decision date: 1996-03-07
Generic name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
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

Current openFDA PMA Record#

Device: TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
Applicant: Hybritech, Inc.
PMA number: P840019
Supplement: S012
Product code: DHX
Generic name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Decision date: 1996-03-07
Decision code: APPR
Date received: 1995-09-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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