HOMOCYSTEINE

Primary DI

D-02B0020YF

Basic UDI-DI Code

B-02B0020YF

Reference

2P001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

Homocysteine (HCY) Reagent Kit is intended to quantitatively determine concentration of HCY in human serum in vitro. Clinically, it is mainly used for the auxiliary diagnosis of hyperhomocysteinemia and atherosclerosis and the risk evaluation for cardiovascular disease. Homocysteine is one of the independent risk factors of stroke, coronary atherosclerosis and myocardial infarction, whose concentration is directly proportional to the risk of disease. Meanwhile, its concentration also serves as a sensitive index of vitamin B12 and folate deficiency in accordance with the metabolic characteristics of homocysteine.

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