Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
Anti-GBM IgG CLIA Microparticles
Devices (same UDI-DI)
3
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06942359513340
- Basic UDI-DI Code
- 697015090000315HC
- Reference
- CMQ1710
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
This Anti-GBM IgG CLIA Microparticles assay is based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of anti-glomerular basement membrane (Anti-GBM) IgG in human serum or plasma. This assay is to be used as an aid in the diagnosis of pulmonary hemorrhage nephritis syndrome (Goodpasture's syndrome), acute glomerulonep
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102109014 | ANTIBODIES TO GLOMERULAR BASAL MEMBRANE |
Available In Countries
🇮🇹 Italy
🇹🇷 Türkiye
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