Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
HbA1c Rapid Quantitative Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208500
- Basic UDI-DI Code
- B-06933260208500
- Reference
- BT2501
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The HbA1c (Glycosylated Hemoglobin A1c) Rapid Quantitative Test is intended to quantify the percentage of HbA1c in human whole blood on Biotime FIA Analyzer by fluorescent immunoassay. The test is used as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060107 | HBA1C TEST STRIPS |
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