Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, ENA Screen I
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030403133
- Basic UDI-DI Code
- B-06924030403133
- Reference
- MY00198
- 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, ENA Screen I assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to extractable nuclear antigens in human serum and plasma as an aid in the diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) or CREST syndrome. It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100102 | ENA SCREENING |
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