Identity
- Trade Name
- ADVIA Centaur® VitD FDA UDI
- Generic Name
- Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ADVIA Centaur® VITAMIN D TOTAL (VITD) ASSAY FDA UDI
- Model / Reference
- 10699201 FDA UDI
- Description
- ADVIA Centaur® VITAMIN D TOTAL (VITD) ASSAY FDA UDI
Identifiers
- Catalog Number
- 10699201 FDA UDI
- Primary DI / UDI-DI
- 00630414592503 FDA UDI
- 510(k) Number
- K133156 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1825 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: Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® VitD by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay.
- ARCHITECT — ABBOTT IRELAND · Class II
- LIAISON® 25 OH Vitamin D TOTAL Assay — Diasorin Inc.
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- Alinity — ABBOTT IRELAND · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- MAGLUMI 2000 25-OH Vitamin D — Shenzhen New Industries Biomedical Engineering Co., Ltd. · Class II
Cleared under the same submission
K133156 also covers:
- ADVIA Centaur® Systems QC VitD — Siemens Healthcare Diagnostics
- ADVIA Centaur® VitD — Siemens Healthcare Diagnostics
- ADVIA Centaur® VitD MCM — Siemens Healthcare Diagnostics
- Atellica IM VitD — Siemens Healthcare Diagnostics
- Atellica IM VitD — Siemens Healthcare Diagnostics
- Atellica IM VitD — Siemens Healthcare Diagnostics
- Atellica IM VitD MCM — Siemens Healthcare Diagnostics
- Atellica IM VitD QC — Siemens Healthcare Diagnostics
- Atellica IM VitD QC — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 57853d61-0cc7-4d69-b0f2-89802db068f1 37 fields · synced May 30, 2026