Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, PM-Scl
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402730
- Basic UDI-DI Code
- B-06924030402730
- Reference
- MY00158
- 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, PM-Scl is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to PM-Scl in human serum and plasma as an aid in the diagnosis of anti-nuclear antibody (ANA) diseases including Systemic Lupus Erythematosus (SLE). It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100109 | PM-SCL - ANTIBODIES |
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