BioCLIA Autoimmune Reagent Kit, Scl-70
Basic Information
- Primary DI
- 06924030415525
- Basic UDI-DI Code
- B-06924030415525
- Reference
- MY00103C
- 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, Scl-70 assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 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, Scl-70 is intended for the calibration of the BioCLIA Scl-70 performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, Scl-70 is intended for the quality control purposes of the BioCLIA Scl-70 performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100110 | SCL-70 |
Similar Devices
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