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IDS-iSYS 1, 25-Dihydroxy Vitamin D Control Set
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref IS-2430
Identity
- Trade Name
- IDS-iSYS 1,25-Dihydroxy Vitamin D Control Set EUDAMEDFDA UDI
- Generic Name
- 1,25-Dihydroxy vitamin D3 IVD, control FDA UDI
- Device Name
- IDS-iSYS 1,25-Dihydroxy Vitamin D Control Set EUDAMED
- Model / Reference
- IS-2430 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690356 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690356 EUDAMED
- 510(k) Number
- K123253 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- 1,25-Dihydroxy vitamin D3 IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
No
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 1, 25-Dihydroxy Vitamin D Control Set by Immunodiagnostic Systems Limited — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123253 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-05060169690356 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (3)
- EUDAMED 092bd163-f528-4563-944b-52cfac57537d 61 fields · synced Jul 30, 2026
- FDA UDI 2195bef4-e6b0-42e1-8b5f-3d6375162fdc 35 fields · synced May 30, 2026
- FDA 510(k) K123253 1 fields · synced May 18, 2026