cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)
FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-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
- 06950996003865
- Basic UDI-DI
- 69509960FDCAR-T402a-DRQ4
- Reference
- FDCAR-T402a-DR10
- EMDN
- W0102160706
- EMDN description
- MULTIPLE CARDIAC MARKERS - RT & POC
- First on market country
- Germany
- Safety summary (SSCP/SSP)
- CEDR-FDCAR-T402a-11-OG · Rev. 4.0
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 18.07.2026 13:49