Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, PR3
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402785
- Basic UDI-DI Code
- B-06924030402785
- Reference
- MY00163
- 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, PR3 assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to PR3 in human serum and plasma as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA) 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 |
|---|---|
| W0102100403 | PR3 ANCA |
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