BioCLIA Autoimmune Reagent Kit, PLA2R
Basic Information
- Primary DI
- 06924030415952
- Basic UDI-DI Code
- B-06924030415952
- Reference
- MY01710C
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
BioCLIA Autoimmune Reagent Kit, PLA2R assay is intended for the in vitro quantitative measurement of autoantibodies to PLA2R in human serum on the fully automatic BioCLIA instrument. The kit is applied as an aid in the diagnosis of idiopathic Membranous Nephropathy (iMN). It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, PLA2R is intended for the calibration of the BioCLIA PLA2R performed on the BioCLIA 6500 and BioCLIA 500 instruments only. The BioCLIA Autoimmune Control Set, PLA2R is intended for the quality control purposes of the BioCLIA PLA2R performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102109099 | AUTO-IMMUNE DISEASE TESTS - OTHER |
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