Identity
- Trade Name
- Atellica IM VitD QC FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
- Device Name
- Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL FDA UDI
- Model / Reference
- 10995724 FDA UDI
- Description
- Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL FDA UDI
Identifiers
- Catalog Number
- 10995724 FDA UDI
- Primary DI / UDI-DI
- 00630414600376 FDA UDI
- 510(k) Number
- K133156 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D 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: Multiple form 25-hydroxy Vitamin D IVD, control
Atellica IM VitD QC by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, control.
- PreciControl Vitamin D total III — Roche Diagnostics Corp. · Class I
- Serum Control — Chromsystems Instruments & Chemicals GmbH · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 — Carolina Liquid Chemistries Corp. · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- Method Verification Kit - Vitamin D — QUALIGEN INC. · Class I
- Diazyme — Diazyme Laboratories, Inc.
- Alinity — ABBOTT IRELAND · Class I
- VITAMIN D PLUS — UTAK LABORATORIES, INC. · Class I
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 — 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
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI f960c689-fbeb-486c-b67a-d6a7848587f5 37 fields · synced May 31, 2026