BioCLIA Autoimmune Reagent Kit, human tTG IgA
Basic Information
- Primary DI
- 06924030415839
- Basic UDI-DI Code
- B-06924030415839
- Reference
- MY00138C
- 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 vitrodiagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, human tTG IgA is intended for the calibration of the BioCLIA human tTG IgA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, human tTG IgA is intended for the quality control purposes of the BioCLIA human tTG IgA performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100601 | TISSUE TRANSGLUTAMINASE ANTIBODIES |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).