BioCLIA Autoimmune Reagent Kit, MDA5
Basic Information
- Primary DI
- 06924030415945
- Basic UDI-DI Code
- B-06924030415945
- Reference
- MY01704C
- 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, MDA5 assay is intended for the in vitro quantitative measurement of IgG antibodies directed to MDA5 in human serum as an aid in the diagnosis of dermatomyositis 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, MDA5 is intended for the calibration of the BioCLIA MDA5 performed on the BioCLIA 6500 and BioCLIA 500 instruments only. The BioCLIA Autoimmune Control Set, MDA5 is intended for the quality control purposes of the BioCLIA MDA5 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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