Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

UREA/BLOOD UREA NITROGEN

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

Basic Information

Primary DI
D-02B0005YK
Basic UDI-DI Code
B-02B0005YK
Reference
1N001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The Urea/Creatinine/Uric Acid Reagent Kit is intended to quantitatively determine urea, creatinine (Crea) and uric acid (UA) in human serum. Clinically, it is mainly used for the monitoring of renal function. Urea is the end product of the metabolic breakdown of proteins in human body. it is synthesized in liver and is excreted mainly after passing to kidney. The Urea measurement in serum is an important indicator for clinical evaluation of renal function. Creatinine is the waste product of creatine metabolized in muscle. and is cleared from the body by kidney, The high levels of blood creatinine is usualv a warning of malfunction or failure of kidney. Blood creatinine is a comparatively accurate indicator that reflects th actual damage of kidney, the concentration of creatinine in blood is thus an important indicator in the evaluation of renal function. UA is the end product of the metabolic breakcdown of purines, and is fitered out of human body through kidney and in urine. A high uric acid level is normally observed in gout patients. For patients with increased nucleosides metabolic. such as leukemia. multiple myeloma polycythemia vera; renal diseases such as acute/chronic nephritis,kidney stone, etc, the uric acid level in blood is significantly higher

CND Nomenclature Codes

Code Description
W01010204 UREA/BLOOD UREA NITROGEN
W01010207 CREATININE
W01010232 URIC ACID

Similar Devices

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

View all