Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
AMA-M2 IgG CLIA Microparticles
Devices (same UDI-DI)
3
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06942359513432
- Basic UDI-DI Code
- 697015090000316HE
- Reference
- CMQ2410
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The AMA-M2 IgG CLIA Microparticles assay is based on a chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of AMA-M2 IgG in human serum and plasma.This assay is to be used as an aid in the diagnosis of primary biliary cholangitis(PBC).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100702 | ANTI-MITOCHONDRIAL ANTIBODIES |
Available In Countries
🇬🇷 Greece
🇹🇷 Türkiye
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