Diagnostic Kit for D-Dimer (DD) (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000570

Basic UDI-DI Code

B-06974521000570

Reference

SUPF015025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for in vitro quantitative detection of the concentration of D-Dimer in human plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of disseminated intravascular coagulation and pulmonary embolism and other related diseases. D-Dimer is a specific degradation product of fibrin monomer cross-linked by activator ⅩⅢ and hydrolyzed by plasmin. It can reflect the coagulation function and fibrinolytic activity in vivo. It is an indicator of hypercoagulability, thrombosis and secondary hyperfibrinolysis. The level of D-Dimer increased in deep venous thrombosis, pulmonary embolism, disseminated intravascular coagulation, severe hepatitis and other diseases, and also increased after thrombolytic therapy, which can be used as an effective observation index for thrombolytic therapy. Due to its high sensitivity and negative predictive value, D-Dimer negative has been clinically used as an important basis to exclude the formation of pulmonary embolism (PE) and deep venous thrombosis (DVT).

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