Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719872951544
- Basic UDI-DI Code
- B-04719872951544
- Reference
- 1544
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- iXensor Co., Ltd.
Additional Description
The PixoTest POCT Analyzer is intended to be used for the quantitative measurement of HbA1c and Lipids (including Total cholesterol, Triglycerides, and High-Density Lipoprotein (HDL) cholesterol) in whole blood from both capillary and venous. Estimated values for Low-Density Lipoprotein (LDL) cholesterol is calculated. The PixoTest POCT Analyzer is a professional use only and intended for in vitro diagnostic use and is not intended for use on neonates. Untrained professional personnel could perform it well.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201010101 | CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) |
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