PixoTest Lipid Test Strip
Basic Information
- Primary DI
- 04719872951551
- Basic UDI-DI Code
- B-04719872951551
- Reference
- 1551
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- iXensor Co., Ltd.
Additional Description
PixoTest Lipid Test Strip is a part of PixoTest EZ - Lipid Monitoring system, The PixoTest Lipid test strip is intended to be used with PixoTest EZ Analyzer. The PixoTest EZ - Lipid Monitoring system is intended to be used for the quantitative measurement of Total Cholesterol (TC), Triglycerides (TG), and High-Density Lipoprotein (HDL) cholesterol in whole blood. Estimated values for Low-Density Lipoprotein (LDL) cholesterol is calculated. The PixoTest EZ - Lipid Monitoring system takes capillary blood as a test sample and the sample shall be applied to PixoTest Lipid Test Strip. The PixoTest EZ - Lipid Monitoring system is intended for in vitro diagnostic use only (outside of the body) and is not intended for use on neonates. PixoTest EZ - Lipid Monitoring system is intended for near-patient testing and is intended to perform testing outside a laboratory environment by a health professional.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010228 | TOTAL LIPIDS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 614409 | BSI Group The Netherlands B.V. | Expired |
Similar Devices
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