Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208272
- Basic UDI-DI Code
- B-06933260208272
- Reference
- BT0507502
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
It is used for in vitro quantitative detection of the Glycated hemoglobin A1c (HbA1c) concentration in human whole blood that contains EDTA or without anticoagulants samples, mainly used for the supervising of long-term glycemic control in diabetic individuals and auxiliary diagnosis of diabetes and identify patients at risk of diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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