BioCLIA Autoimmune Reagent Kit, MPO
Basic Information
- Primary DI
- 06924030415600
- Basic UDI-DI Code
- B-06924030415600
- Reference
- MY00111C
- 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, MPO assay is intended for the in vitro quantitative / semi-quantitative measurement of IgG antibodies directed to vasculitis cells in human serum / plasma as an aid in the diagnosis of autoimmune vasculitis diseases 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, MPO is intended for the calibration of the BioCLIA MPO performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, MPO is intended for the quality control purposes of the BioCLIA MPO performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100402 | MPO ANCA |
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