HbA1c Quantitative Test Kit (Time-Resolved FIA)
FIHBA-402a-DR10, FIHBA-402a-DR10LH, FIHBA-402a-DR10HG, FIHBA-402a-DR, FIHBA-402a-DRLH, FIHBA-402a-DRHG
IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- 06950996003940
- Basic UDI-DI
- 69509960FIHBA-402a-DRES
- Reference
- FIHBA-402a-DR10
- EMDN
- W0102160102
- EMDN description
- GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
- First on market country
- Germany
- Safety summary (SSCP/SSP)
- CEDR-FIHBA-402a-11.1-OG · Rev. 3.0
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 18.07.2026 13:49