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For in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen (CEA) in serum and plasma (EDTA and lithium heparin) to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems.

The assay reagents come in the following configurations: 5 ReadyPack primary reagent packs containing ADVIA Centaur CEA Lite Reagent and Solid Phase ADVIA Centaur CEA Master Curve card (500 Tests) 1 ReadyPack primary reagent pack containing ADVIA Centaur CEA Lite Reagent and Solid Phase ADVIA Centaur CEA Master Curve card (100 Tests) The ReadyPack consists of the following: ADVIA Centaur® CEA ReadyPack® primary reagent pack; Lite Reagent: 5.0 mL/reagent pack polyclonal rabbit anti-CEA antibody (~400 ng/mL) labeled with acridinium ester in phosphate buffered saline with protein stabilizers, sodium azide (0.12%), and preservatives ADVIA Centaur® CEA ReadyPack® primary reagent pack; Solid Phase Reagent: 25.0 mL/reagent pack monoclonal mouse anti-CEA antibody (~120 µg/mL) covalently coupled to paramagnetic particles in phosphate buffered saline with protein stabilizers, sodium azide (0.11%), and preservatives ADVIA Centaur® CEA ReadyPack® ancillary reagent pack; CEA Diluent: 5.0 mL/reagent pack bicine buffer, gelatin, and BSA with preservatives and sodium azide (0.1%) ADVIA Centaur® CEA Diluent: 10.0 mL/reagent vial bicine buffer, gelatin, and BSA with preservatives and sodium azide (0.1%)