BioCLIA Autoimmune Reagent Kit, DGP IgG
Basic Information
- Primary DI
- 06924030415860
- Basic UDI-DI Code
- B-06924030415860
- Reference
- MY00141C
- 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, DGP IgG assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to deamidated gliadin peptide 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. The BioCLIA Autoimmune Calibrator Set, DGP IgG is intended for the calibration of the BioCLIA DGP IgG performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, DGP IgG is intended for the quality control purposes of the BioCLIA DGP IgG performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100699 | CELIAC DISEASE - OTHER |
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