Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, CCP
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402983
- Basic UDI-DI Code
- B-06924030402983
- Reference
- MY00183
- 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021199 | RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER |
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