Identity
- Trade Name
- N-MID® Osteocalcin ELISA EUDAMEDFDA UDI
- Generic Name
- Osteocalcin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- N-MID® Osteocalcin ELISA EUDAMED
- Model / Reference
- AC-11F1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690516 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690516 EUDAMED
- 510(k) Number
- K003609 FDA UDI
- FDA Product Code
- NEO FDA UDI
- EMDN Code
- W0102060311 OSTEOCALCINE EUDAMED
- GMDN Term
- Osteocalcin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1050 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
No
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
N-MID® Osteocalcin ELISA by Immunodiagnostic Systems Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-05060169690516 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED 4a229039-367d-40a0-bb3e-3741aeba43cf 61 fields · synced Aug 3, 2026
- FDA UDI c6b0ea9e-d25c-4137-bcd3-3d6a52ad6626 35 fields · synced May 27, 2026