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CP3000 analyzer: The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays. Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. Coagpia Calibrator: The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. - Coagpia AT Reagent Coagpia Control Set: The Coagpia Control Set contains 2 levels of assaved plasma intended for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use. - Coagpia AT Reagent

CP3000: The CP3000 is designed for easy-to-use, rapid in-vitro blood coagulation testing on citrated human plasma. The CP3000 system is capable of performing the chromogenic methodologic assay, giving the user the ability to perform analysis for both direct hemostasis measurements and calculated parameters. For these assay methodologies, the analyzers employs two photometric detection methods: light scattering and absorbance. The light scattering method uses light emitting diodes at a wavelength of 660 nm, and the absorbance method uses a halogen lamp with filters providing wavelengths at 405/570/730 nm. Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human plasma on the CP3000 analyzers. The reagent is supplied in a kit of 2 x 10 mL of Reagent 1 and 1 x 10mL of Reagent 2. Both reagents are liquid and do not require any preparation prior to use. Coagpia Calibrator: The Coagpia Calibrator is supplied as 10 vials of lyophilized human plasma and is suitable for the calibration of the antithrombin activity assay using Coagpia AT Reagent on the CP3000 coagulation analyzers. Coagpia Control Set: The Coagpia Control Set is supplied as10 vials of lyophilized human plasma; 5 vials of Level 1 Control and 5 vials of Level 2 Control and is suitable for use with the antithrombin activity assay using Coagpia AT Reagent on the CP3000 analyzers.