BioCLIA Autoimmune Reagent Kit, gp210
Basic Information
- Primary DI
- 06924030415631
- Basic UDI-DI Code
- B-06924030415631
- Reference
- MY00114C
- 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, gp210 assay s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gp210 in human serum and plasma as an aid in the diagnosis of autoimmune liver diseases (ALD) in conjunction with other laboratory and clinical findings. It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, gp210 is intended for the calibration of the BioCLIA gp210 performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, gp210 is intended for the quality control purposes of the BioCLIA gp210 performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100799 | AUTOIMMUNE HEPATITIS - OTHER |
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