Identity
- Trade Name
- Elecsys Vitamin B12 II CalSet FDA UDI
- Generic Name
- Vitamin B12 IVD, calibrator FDA UDI
- Model / Reference
- 07212780190 FDA UDI
Identifiers
- Catalog Number
- 07212780190 FDA UDI
- Primary DI / UDI-DI
- 04015630939480 FDA UDI
- 510(k) Number
- K151786 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Vitamin B12 IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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: Vitamin B12 IVD, calibrator
Elecsys Vitamin B12 II CalSet by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitamin B12 IVD, calibrator.
- ARCHITECT — ABBOTT IRELAND · Class II
- Alinity — Abbott · Class II
- ARCHITECT — Abbott · Class II
- Alinity — ABBOTT IRELAND · Class II
Cleared under the same submission
K151786 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI bfff9266-f04e-4053-8e2e-cd20dffac9a3 35 fields · synced Jun 8, 2026