Identity
- Trade Name
- Atellica IM Calibrator O FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator FDA UDI
- Device Name
- Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL FDA UDI
- Model / Reference
- 10995516 FDA UDI
- Description
- Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 10995516 FDA UDI
- Primary DI / UDI-DI
- 00630414598437 FDA UDI
- 510(k) Number
- K003291 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5870 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: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
Atellica IM Calibrator O by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator.
Cleared under the same submission
K003291 also covers:
- IMMULITE® 2000 Systems Anti-TPO CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- ADVIA Centaur® Systems Calibrator 0 — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems QC anti-TPO 1, 2 — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTPO — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTPO +0 — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTPO Diluent — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTPO MCM — Siemens Healthcare Diagnostics
- Atellica IM aTPO — Siemens Healthcare Diagnostics
- Atellica IM aTPO — Siemens Healthcare Diagnostics
- Atellica IM aTPO DIL — Siemens Healthcare Diagnostics
- Atellica IM aTPO MCM — Siemens Healthcare Diagnostics
- Atellica IM aTPO 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 674fa560-a567-413c-8eeb-4cce0965fc0d 37 fields · synced Jun 8, 2026