Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
Anti-nRNP/Sm IgG CLIA Microparticles
Devices (same UDI-DI)
3
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06942359512961
- Basic UDI-DI Code
- 697015090000311H4
- Reference
- CMQ2108
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The Anti-nRNP/Sm IgG CLIA Microparticles assay is based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of anti-nRNP/Sm IgG in human serum or plasma.This assay is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus（SLE）and Mixed connective tissue disease (MCTD).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100199 | AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER |
Available In Countries
🇮🇹 Italy
🇷🇴 Romania
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