Eu Ivdr
Eu Ivd Class C
On The Market
🇨🇳 China
HER-2/neu CLIA Microparticles
Devices (same UDI-DI)
2
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06942359525473
- Basic UDI-DI Code
- 697015090000132H2
- Reference
- CMB2210
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The HER-2/neu CLIA Microparticles assay and AutoLumo HER-2/neu Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of human epidermal growth factor receptor 2 (HER-2/neu) protein in human serum. HER-2/neu is used for dynamic monitoring of patients, which acts as an aid of disease progression or treatment determination of breast cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030301 | HER-2/NEU |
Available In Countries
🇮🇹 Italy
🇷🇴 Romania
🇹🇷 Türkiye
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