Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
LabonaCheck™ A1c Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065168002
- Basic UDI-DI Code
- B-08800065168002
- Reference
- MH200C10
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
Quality control using the LabonaCheck™ A1c Control Solution should be performed to confirm that the LabonaCheck™ A1c HbA1c Analyzer and LabonaCheck™ A1c HbA1c Test Kit are working properly. Only when the control solution is used routinely and the values obtained are within the acceptable ranges, the accuracy of test results can be assured.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050205 | DIABETES CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | Q5 091763 0014 | TÜV SÜD Product Service GmbH | Expired |
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