Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
CERA-STAT™ HbA1c Control Solution
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800065178001
- Basic UDI-DI Code
- B-08800065178001
- Reference
- CS400C10
- 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 CERA-STAT™ HbA1c Control Solution should be performed to confirm that the CERA-STAT™ 4000 Analyzer and CERA-STAT™ HbA1c Test Kit is 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 |
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