Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

BETA2-MICROGLOBULIN

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

Basic Information

Primary DI
D-02B0003YF
Basic UDI-DI Code
B-02B0003YF
Reference
1O001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The β2-Microglobulin/Cystatin C Reagent Kit is intended to quantitatively determine β2-microglobulin and cystatin C in human serum. Clinically, it is mainly used for auxiliary diagnosis of renal diseases. Cys C is an ideal marker for indicating renal diseases. Cys C widely exists in human body fluid such as blood, cerebrospinal fluid, saliva, semen, etc. Cys C can pass through glomerular filtration membrane freely. It is reabsorbed by proximal convoluted tubule and no longer participate in blood circulation. As kidney tubules do not generate Cys C, the change in the Cys C concentration in blood reflects the glomerular filtration rate, which thus indicates the state of renal function, including renal injury. β2-MG: the β2-MG concentration in the blood of patients with malignant lymphoma, chronic lymphocytic leukemia, non-Hodgkin's lymphoma or multiple myeloma etc. are significantly higher, and is highly related to the state of the disease. The β2-MG concentration in the blood of patients with uremia, nephritic syndrome and acute renal failure are also significantly higher.

CND Nomenclature Codes

Code Description
W0102039002 BETA2-MICROGLOBULIN
W0102019008 CYSTATIN C

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