Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
LabonaCheck™ A1c HbA1c Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800065142101
- Basic UDI-DI Code
- B-08800065142101
- Reference
- MH200S10
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The LabonaCheck™ A1c HbA1c Test kit is intended for the quantitative determination of glycated hemoglobin in human blood. The LabonaCheck™ A1c is a boronate affinity assay. The LabonaCheck™ A1c HbA1c Test kit consists of the cartridges, the R1/Reagent and the R2/Reagent.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060107 | HBA1C TEST STRIPS |
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