Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
CERA-STAT™ 2000 HbA1c Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800065144105
- Basic UDI-DI Code
- B-08800065144105
- Reference
- CS200S10
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The CERA-STAT™ 2000 HbA1c Test kit is intended for the quantitative determination gycated hemoglobin in human blood. It also provide the Estimated average glucose(eAG) value, in addition to the gycated hemoglobin result, allowing for easier diabetes care. The CERA-STAT™ 2000 HbA1c Test kit is a boronate affinity assay. The CERA-STAT™ 2000 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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