Anti-Scl-70 IgG CLIA Microparticles
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Basic Information
- Primary DI
- 06942359512718
- Basic UDI-DI Code
- 697015090000308HF
- Reference
- CMQ1810
- 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-Scl-70 IgG CLIA Microparticles assay is based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of anti-topoisomerase I IgG antibody (anti-Scl-70 IgG) in human serum or plasma.This assay is to be used as an aid in the diagnosis of systemic scleroderma.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100110 | SCL-70 |
Available In Countries
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Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).