D-DIMER

Primary DI

D-02B0019YW

Basic UDI-DI Code

B-02B0019YW

Reference

2N001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

D-Dimer Reagent Kit is intended to quantitatively determine the concentration of D-Dimer in human plasma. D-Dimer is a specific degradation product of cross-linked fibrin hydrolyzed by plasmin, which mainly reflects the fibrinolytic function. Increased D-Dimer concentration or positive D-Dimer is seen in secondary hyperfibrinolysis, such as hypercoagulable state, disseminated intravascular coagulation, renal disease, rejection in organ transplantation, and thrombolytic therapy, etc. The increase in D-Dimer concentration is attributed to myocardial infarction, cerebral infarction, pulmonary embolism (PE), venous thrombosis, operation, tumor, diffuse intravascular coagulation (DIC), infection and tissue necrosis. Therefore, D-Dimer often serves as a key maker for deep venous thrombosis (DVT), PE and DIC. Clinically, it is mainly used for preclusion of venous thrombosis, auxiliary diagnosis of DIC, and monitoring of thrombolytic therapy.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).