D-DIMER (DIC, TVT)

This product is a near-patient immunological test for the qualitative detection of D-dimer in capillary blood from the fingertip, citrated blood and citrated plasma. The test serves as a diagnostic aid to exclude deep vein thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation disorders (DIC).

The test is intended exclusively for use by medically trained personnel and is not intended for over-the-counter (OTC) sale. The product must not be used as the sole basis for diagnostic decisions. The results of the test must be validated in the context of the clinical history and by a laboratory confirmation test.

It is a non-automated product that has been specifically developed for patient-centred diagnostics.