Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit dsDNA
Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402129
- Basic UDI-DI Code
- 6924030BioCLIAAI3N
- Reference
- MY00097
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
The BioCLIA Autoimmune Reagent Kit, dsDNA assay is intended for the in vitro quantitative measurement of IgG antibodies directed against double stranded deoxyribonucleic acid (dsDNA) in human serum/plasma as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and related autoimmune diseases. It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100105 | DS DNA - ANTIBODIES |
Available In Countries
🇩🇪 Germany
🇬🇷 Greece
ðŸ‡ðŸ‡· Croatia
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