BioCLIA Autoimmune Reagent Kit, DGP IgA
Basic Information
- Primary DI
- 06924030415853
- Basic UDI-DI Code
- B-06924030415853
- Reference
- MY00140C
- 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 IgA assay is intended for the in vitro semi-quantitative measurement of IgA 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 IgA is intended for the calibration of the BioCLIA DGP IgA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, DGP IgA is intended for the quality control purposes of the BioCLIA DGP IgA performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100699 | CELIAC DISEASE - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).