Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, IAA
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402990
- Basic UDI-DI Code
- B-06924030402990
- Reference
- MY00184
- 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, IAA assay is intended for the in vitro semi-quantitative measurement of insulin autoantibody (IAA) in human serum as an aid in the diagnosis of insulin-dependent diabetes mellitus (IDDM), latent autoimmune diabetes of adults (LADA) or 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 |
|---|---|
| W0102060104 | INSULIN ANTIBODY |
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