Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
VivaDiag Plus Hemoglobin Test Strips
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-VOS01-01199
- Basic UDI-DI Code
- B-VOS01-01199
- Reference
- VOS01-011
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
Additional Description
The Hemoglobin Test Strips are firm plastic strips onto which a multilayer dry reagent is affixed and are intended to be read on the VivaDiag Plus Hemoglobin Meter. The test strip’s function is lysing erythrocytes and converting the released hemoglobin into methemoglobin. This test is for the quantitative determination of hemoglobin (Hb) and calculation hematocrit (Hct) in capillary and venous whole blood. Use with VivaDiag Plus Hemoglobin Meter Only. The test strips are for professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102070105 | RETICULOCYTE HAEMOGLOBIN CONTENT |
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