Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, human tTG IgA
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030403041
- Basic UDI-DI Code
- B-06924030403041
- Reference
- MY00189
- 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, human tTG IgA assay is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase in human serum and plasma as an aid in the diagnosis of celiac disease (CD). It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100601 | TISSUE TRANSGLUTAMINASE ANTIBODIES |
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