D-Dimer

Primary DI

16438153000744

Basic UDI-DI Code

6438153BU00062BP

Reference

981946

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

For in vitro diagnostic use in the quantitative determination of D-dimer concentration in human plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ (60, 30, 20XT) analyzers. The D-Dimer test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of venous thromboembolism (VTE), disseminated intravascular coagulation (DIC) and fibrinolytic states, in patients. In particular, the D-Dimer test is indicated to be used in conjunction with clinical evaluation as aid for excluding VTE in patients, specifically deep vein thrombosis (DVT) and pulmonary embolism (PE). Furthermore, the D-Dimer test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of a recurrent thrombotic risk following anticoagulation, post-surgical state, significant liver disease, malignancy and normal pregnancy, in patients.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).