Identity
- Trade Name
- ADVIA Centaur® VB12 MCM FDA UDI
- Generic Name
- Vitamin B12 IVD, control FDA UDI
- Device Name
- Vitamin B12 - Master Curve Material Set - CENTAUR - CONS FDA UDI
- Model / Reference
- 10309760 FDA UDI
- Description
- Vitamin B12 - Master Curve Material Set - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 104523 FDA UDI
- Primary DI / UDI-DI
- 00630414054124 FDA UDI
- 510(k) Number
- K993571 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Vitamin B12 IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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, control
ADVIA Centaur® VB12 MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitamin B12 IVD, control.
- LIAISON® Vitamin B12 Control Set — Diasorin Inc.
- ARCHITECT — ABBOTT IRELAND · Class II
- Alinity — Abbott · Class I
- IMMULITE® Systems VB Calibration Verification Material Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott · Class I
- Alinity — ABBOTT IRELAND · Class I
- Audit MicroControls Linearity FLQ Active B12 — Aalto Scientific, Ltd.
- VITROS — Ortho-Clinical Diagnostics · Class I
Cleared under the same submission
K993571 also covers:
- ADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics
- ADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator C — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 +C — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 DTT/Releasing Agent — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 Diluent — Siemens Healthcare Diagnostics
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics
- Atellica IM VB12 — Siemens Healthcare Diagnostics
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 67ec322b-3faa-4d20-9009-d72a7d273f70 37 fields · synced Jun 8, 2026