Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
Anti-Sm IgG CLIA Microparticles
Devices (same UDI-DI)
3
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06942359512879
- Basic UDI-DI Code
- 697015090000310H2
- Reference
- CMQ2008
- 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-Sm IgG CLIA Microparticles assay is based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of anti-Sm IgG in human serum or plasma.This assay is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus(SLE).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100111 | SM |
Available In Countries
🇮🇹 Italy
🇹🇷 Türkiye
Related Devices
The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).
IDS ACE
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·14 countries
IDS SHBG
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
IDS SHBG Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
Serum CrossLaps® (CTX-I) ELISA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·32 countries