BioCLIA Autoimmune Reagent Kit, CCP
Basic Information
- Primary DI
- 06924030415815
- Basic UDI-DI Code
- B-06924030415815
- Reference
- MY00132C
- 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, CCP assay is intended for the in vitro semi-quantitative measurement of anti-cyclic citrullinated peptides antibody (Anti-CCP) in human serum and plasma as an aid in the diagnosis of rheumatoid arthritis (RA) and other related disorders 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, CCP is intended for the calibration of the BioCLIA CCP performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, CCP is intended for the quality control purposes of the BioCLIA CCP performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021110 | RHEUMATOID FACTORS |
Similar Devices
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