For in vitro diagnostic use. Instrument CoaguChek XS IVD CoaguChek® XS system INS_804 04625412174 CoaguChek XS Kit Japan CoaguChek® XS system 07613336141915 Meters Not Available Not Available The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood. en   Detection systemAmperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastinUser interface: Icon-based LCD display; on/off, mem and set buttonsMeasuring rangeINR: 0.8 - 8.0%Quick: 120 - 5Seconds: 9.6 - 96 en The CoaguChek XS PT test strip contains a lyophilized reagent (reagent in dried form). The reactive components of this reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thrombo- plastin activates coagulation, which leads to the formation of thrombin. At the same time the meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending on the time elapsed when it first appears, this signal is then converted by means of an algorithm into customary coagulation units (INR, %Quick, seconds) and the result is displayed. en