Basic Information
- Primary DI
- D-8800210900068V9
- Basic UDI-DI Code
- B-8800210900068V9
- Reference
- AHA1C-8010
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- CareforU.Co.Ltd
Additional Description
The HUBI A1c Test Cartridge, together with the HUBI DIA Analyzer, which are part of the HUBI A1C measuring system provides a convenient method for measuring the percent concentration of hemoglobin A1c (HbA1c %) in both capillary blood and whole venous blood. The measurement of hemoglobin A1c concentration is recommended for monitoring the average blood glucose levels for the long-tern care of people with diabetes. The HUBI A1c Test Cartridge uses boronate affinity chromatography to separate the glycated hemoglobin fraction from the nonglycated fraction. The HUBI A1c Test Cartridge is intended to be used by professionals in laboratories, clinics and hospitals
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060107 | HBA1C TEST STRIPS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).