C-REACTIVE PROTEIN - RT & POC

Primary DI

D-02B0009YT

Basic UDI-DI Code

B-02B0009YT

Reference

1E001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The C-Reactive Protein Reagent Kit is intended to quantitatively determine the concentration of C-reactive protein in human serum, venous whole blood, and capillary whole blood. The full-range C-reactive protein includes conventional C-reactive protein (CRP) and hypersensitive C-reactive protein (hs-CRP). CRP, mainly used as an inflammatory marker, is mainly used to evaluate infection, tissue injury and inflammatory diseases. CRP is a (acute-phase) protein in blood which rises rapidly when organism is infected or when tissues are damaged. It activates complement and intensifies phagocyte ingestion, clearing the invading pathogenic microorganism and histiocyte that is damaged, necrotic or apoptotic. When used as a highly sensitive indicator of acute-phase response, the full-range CRP level in blood experiences a quick and significant increase and can reach up to 2000 times normal in condition of acute myocardial infarction, wound, infection, inflammation, surgery and tumor-infiltrating. hs-CRP is commonly used clinically as an auxiliary means to identify the risk of cardiovascular disease. Combined with the traditional clinical use of acute coronary syndrome, it can be used as an early warning indicator of the recurrence of coronary artery disease or acute coronary syndrome.

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