BioCLIA Autoimmune Reagent Kit, Ro52
Basic Information
- Primary DI
- 06924030415532
- Basic UDI-DI Code
- B-06924030415532
- Reference
- MY00104C
- 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, Ro52 assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro52 in human serum and plasma as an aid in the diagnosis of anti-nuclear antibody (ANA) 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, Ro52 is intended for the calibration of the BioCLIA Ro52 performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, Ro52 is intended for the quality control purposes of the BioCLIA Ro52 performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100199 | AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).