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25-Hydroxy Vitamin DS EIA
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref AC-57SF1
Identity
- Trade Name
- 25-Hydroxy Vitamin DS EIA EUDAMEDFDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 25-Hydroxy Vitamin DS EIA EUDAMED
- Model / Reference
- AC-57SF1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690455 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169690455X8 EUDAMED
- 510(k) Number
- K142351 FDA UDI
- FDA Product Code
- MRG FDA UDI
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1825 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
New Device
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
25-Hydroxy Vitamin DS EIA by Immunodiagnostic Systems Limited — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142351 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 5060169690455X8 | Class B | 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 c2b4a2e0-570f-4aa6-9c83-a87bebc5a2bd 61 fields · synced Jun 20, 2026
- FDA UDI ac3f6a15-4af2-480e-9f43-8fe1d3a41acf 35 fields · synced May 30, 2026
- FDA 510(k) K142351 1 fields · synced May 18, 2026