Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-02B0008YR
- Basic UDI-DI Code
- B-02B0008YR
- Reference
- 1U001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Glucose/Glycated Serum Albumin Reagent kit is intended to quantitatively determine the concentration of glucose (Glu) and the ratio of glycated serum albumin (GA) and albumin (ALB) concentration in human serum. Clinically, it is mainly used for the short-term monitoring of glycemic control. The glucose concentration in serum reflects the status of glycemic control in real-time. Glycated serum albumin is the end product of albumin glycosylation, which reflects the average glucose level in a period of time, and can be seen as a sensitive indicator of glucose control efficiency.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010201 | ALBUMIN (CC) |
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