BioCLIA Autoimmune Reagent Kit, dsDNA
Basic Information
- Primary DI
- 06924030415464
- Basic UDI-DI Code
- B-06924030415464
- Reference
- MY00097C
- 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, dsDNA assay is intended for the in vitro quantitative measurement of IgG antibodies directed against double stranded deoxyribonucleic acid (dsDNA) in human serum/plasma as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and related autoimmune diseases. It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, dsDNA is intended for the calibration of the BioCLIA dsDNA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, dsDNA is intended for the quality control purposes of the BioCLIA dsDNA performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100105 | DS DNA - ANTIBODIES |
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