Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-04B0001Z5
- Basic UDI-DI Code
- B-04B0001Z5
- Reference
- 2K001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Glycosylated Hemoglobin Test Kit is intended to quantitatively determine glycated hemoglobin (HbA1c) in human fresh capillary whole blood or venous whole blood. Clinically, it is mainly used for auxiliary diagnosis of diabetes and monitoring of blood glucose level.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010214 | GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) |
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