Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, Sm
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402679
- Basic UDI-DI Code
- B-06924030402679
- Reference
- MY00152
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
The BioCLIA Autoimmune Reagent Kit, Sm assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma as an aid in the diagnosis of antinuclear antibody (ANA) diseases in conjunction with other laboratory and clinical findings. It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100111 | SM |
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