Identity
- Trade Name
- Elecsys N-MID Osteocalcin FDA UDI
- Generic Name
- Osteocalcin IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 07027591190 FDA UDI
Identifiers
- Catalog Number
- 07027591190 FDA UDI
- Primary DI / UDI-DI
- 04015630940462 FDA UDI
- 510(k) Number
- K051297 FDA UDI
- FDA Product Code
- NEO FDA UDI
- GMDN Term
- Osteocalcin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Osteocalcin IVD, kit, chemiluminescent immunoassay
Elecsys N-MID Osteocalcin by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osteocalcin IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 684c2e4a-ee61-4a40-9f8f-1f58c1337d98 35 fields · synced Jun 8, 2026