BioCLIA Autoimmune Reagent Kit, PR3
Basic Information
- Primary DI
- 06924030415617
- Basic UDI-DI Code
- B-06924030415617
- Reference
- MY00112C
- 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, PR3 assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to PR3 in human serum and plasma as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA) 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, PR3 is intended for the calibration of the BioCLIA PR3 performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, PR3 is intended for the quality control purposes of the BioCLIA PR3 performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100403 | PR3 ANCA |
Similar Devices
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