cTnI Quantitative Test Kit (Time-Resolved FIA)
FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-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
- 06950996055918
- Basic UDI-DI
- 69509960FDTRO-402b-DRDH
- Reference
- FDTRO-402b-DRHG
- EMDN
- W0102160703
- EMDN description
- TROPONIN I/T - RT & POC
- First on market country
- Germany
- Safety summary (SSCP/SSP)
- CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 13.10.2026 10:35