Eu Ivdd
Eu Ivd General
On The Market
🇹🇼 Taiwan
PixoTest HbA1c Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719872951254
- Basic UDI-DI Code
- B-04719872951254
- Reference
- 1254
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- iXensor Co., Ltd.
Additional Description
The PixoTest Alc Test Kit is intended to be used for the quantitative measurement of glycated hemoglobin (HbA1c) in human capillary or venous whole blood on PixoTest POCT Analyzer. The PixoTest A1c Test Kit is intended for in vitro diagnostic use only (outside of the body) and for professional use to monitor glycemic control in people with diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060107 | HBA1C TEST STRIPS |
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