Device typeD-dimer IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of D-dimer protein in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses as an aid in the diagnosis of conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), or disseminated intravascular coagulation (DIC). It is not intended to be used for self-testing.
FDA categoryFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device ID00895160002151
Catalog numberCD7153
Single useYes
MRI safetyLabeling does not contain MRI Safety Information