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IDS-iSYS Insulin-like Growth Factor-I (IGF-I)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref IS-3900
Identity
- Trade Name
- IDS-iSYS Insulin-like Growth Factor-I (IGF-I) EUDAMEDIDS-iSYS Insulin like Growth Factor-1 (IGF-1) FDA UDI
- Generic Name
- Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IDS-iSYS Insulin-like Growth Factor-I (IGF-I) EUDAMED
- Model / Reference
- IS-3900 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690288 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690288 EUDAMED
- FDA Product Code
- OAM FDA UDI
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
- GMDN Term
- Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1550 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
IDS-iSYS Insulin-like Growth Factor-I (IGF-I) by Immunodiagnostic Systems Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060169690288 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED 778ebffb-dd7f-4038-a189-359edf9db53f 61 fields · synced Jul 16, 2026
- FDA UDI a3702352-a488-42f9-82fd-90ca96be4949 34 fields · synced May 30, 2026