Basic Information
- Primary DI
- 08800210900051
- Basic UDI-DI Code
- 8800210900058G
- Reference
- AHD-8001
- Device Types
-
Single use New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- CareforU.Co.Ltd
Additional Description
The HUBI DIA Analyzer is a compact and fully automated multi-assay for point of care testing, consisting of HUBI DIA Analyzer and Reagent Cartridges. It is designed to perform quantitative measurements for multi test parameters and intended to be used professionals for IVD(ln Vitro Diagnostic) use only. This HUBI DIA Analyzer system is designed to help controlling diabetes, chronic disease and infection disease. it is intended to be used by professionals in laboratories, clinics and hospitals. Same as all diagnostic tests, do not make a definitive diagnosis of disease based on the result of a single test. A physician should make a diagnosis after all clinical and laboratory findings are evaluated.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060499 | MULTIPLE PARAMETERS POC - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).