Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
CERA-STAT™ 2000 HbA1c Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065176007
- Basic UDI-DI Code
- B-08800065176007
- Reference
- CS200C10
- 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™ 2000 HbA1c Control Solution should be performed to confirm that the CERA-STAT™ 2000 Analyzer and CERA-STAT™ 2000 HbA1c Test Kit are working properly. Only when the control solutions are 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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