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cTnI Quantitative Test Kit (Time-Resolved FIA)

EUDAMED

Class IVD General (EU MDR)

Ref FDTRO-402b

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name
cTnI Quantitative Test Kit (Time-Resolved FIA) EUDAMED
Device Name
cTnI Quantitative Test Kit (Time-Resolved FIA) EUDAMED
Model / Reference
FDTRO-402b EUDAMED

Identifiers

Primary DI / UDI-DI
D-FDTRO-402bCS EUDAMED
Basic UDI-DI
B-FDTRO-402bCS EUDAMED
EMDN Code
W01021306 TROPONIN I/T EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

The cTnI Quantitative Test Kit (Time-Resolved FIA) is a medical device designed for quantitative testing of cardiac troponin levels, providing accurate and reliable results in clinical settings. This innovative kit combines time-resolved fluorescence analysis with a high-throughput plate-based assay to detect and quantify cardiac troponin proteins.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
EUDAMED SRN
CN-MF-000017965
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 2dca0c63-e75c-46c7-93cc-91c3fbfce05f 61 fields · synced Oct 6, 2026