Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

URIC ACID

Changsha Sinocare Inc. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-02B0001YB
Basic UDI-DI Code
B-02B0001YB
Reference
1Q001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The Glucose/Homocysteine/Uric Acid/Low Density Lipoprotein Cholesterol Reagent kit is intended to quantitatively determine the concentration of glucose (Glu), homocysteine (HCY), uric acid (UA) and low density lipoprotein cholesterol (LDL-C) in human serum. Clinically, it is mainly used for the monitoring of glycemic level, auxiliary diagnosis of hyperhomocysteinemia, hyperuricemia, hypercholesteremia, coronary heart disease, atherosclerosis and the risk evaluation of cardiovascular diseases. The glucose concentration in serum reflects the status of glycemic control in real-time. Strict control of blood glucose level is essential in the prevention and treatment of blood glucose disorder such as diabetes. Homocysteine is one of independent risk factors for the development of stroke, coronary arteriosclerosis and myocardial infarction, where high levels of homocysteine increases the risk of developing the diseases. Meanwhile, according to its metabolism feature, homocysteine concentration is also a sensitive indicator of vitamin B12 deficiency and folic acid deficiency. UA is the end product of the metabolic breakdown of purines, and is filtered out of human body through kidney and in urine. In normal condition, the uric acid level in human body is in dynamic equilibrium. Elevated uric acid level is normally observed in patients with renal diseases. Thus, UA measurement is used as an aid in the diagnosis of early-stage renal injury. Low density lipoprotein cholesterol can reflect the level of low density lipoprotein, which is also known as an atherogenic factor. Higher ratio of low density lipoprotein cholesterol among total cholesterol indicates increased risk of atherosclerosis. The precise measurement of low density lipoprotein cholesterol is significant in early prevention, diagnosis, treatment and curative effect of coronary heart disease, and is the main reference basis of prescription determination for hyperlipoproteinemia patients.

CND Nomenclature Codes

Code Description
W01010232 URIC ACID
W01021307 HOMOCYSTEINE
W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
W01010213 GLUCOSE

Similar Devices

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

View all