Eu Ivdr
Eu Ivd Class A
On The Market
🇨🇳 China
Automatic Biochemistry Analyzer
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06950996035330
- Basic UDI-DI Code
- 69509960Diag-H200DS
- Reference
- Diag-H200
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
Additional Description
The Automatic Biochemistry Analyzer (Model: Diag-H200) can be used for in vitro quantitative detection of clinical chemistry analytes in human lithium-heparinized whole blood, heparinized plasma or serum, and is expected to be used for clinical auxiliary diagnosis. It can be applied to medical service points and near-patient testing environment. For near-patient testing and laboratory professional use only. For in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201010101 | CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) |
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