Identity
- Trade Name
- RIA-gnost FT3 EUDAMED
- Device Name
- OCFH07-FT3 EUDAMEDOCFH57-FT3 EUDAMED
- Model / Reference
- OCFH07-FT3 EUDAMEDOCFH57-FT3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770024321364 EUDAMED03770024321371 EUDAMED
- Basic UDI-DI
- B-03770024321364 EUDAMEDB-03770024321371 EUDAMED
- EMDN Code
- W01020405 TRIIODOTHYRONINE EUDAMEDW01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
RIA-gnost FT3 by Cisbio Bioassays — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03770024321364 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cisbio Bioassays
- EUDAMED SRN
- FR-MF-000024051
Sources (2)
- EUDAMED a2088e76-ac1c-45ad-a2e9-92626bfe490b 61 fields · synced Jul 20, 2026
- EUDAMED 63b04baf-62b5-4029-af4a-1723ee0216cb 61 fields · synced May 19, 2026