Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
respons®A1c Hemoglobin A1c Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08806134660750
- Basic UDI-DI Code
- B-08806134660750
- Reference
- 963207
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GC Medical Science Corporation
Additional Description
The respons®A1c Hemoglobin A1c Test Kit is intended for use with the respons®A1c Analyzer by healthcare professionals for near patient testing to quantitatively measure of glycated hemoglobin (hemoglobin A1c, HbA1c) in both capillary and venous whole blood. It aids in diabetes care by providing the estimated average glucose(eAg) value and glycated hemoglobin result. This test kit is in for vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060107 | HBA1C TEST STRIPS |
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