General coagulation IVDs

Intended purpose

IVD systems are intended to be used in combination with whole blood to generate a blood sample to provide quantitative and qualitative indications about the coagulation state of a blood sample as well as the time taken for a clinical blood sample to clot after initiation of intrinsic and/or extrinsic coagulation pathways. Different parameters of coagulation are measured, analysed, monitored and interpreted (clot constitution) and kinetic changes as the clot retracts and/or lyses (breaks apart) are recorded.