Identity
- Trade Name
- Atellica IM aTG FDA UDI
- Generic Name
- Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- TG Ab - Atellica IM - RGT 100T FDA UDI
- Model / Reference
- 10995461 FDA UDI
- Description
- TG Ab - Atellica IM - RGT 100T FDA UDI
Identifiers
- Catalog Number
- 10995461 FDA UDI
- Primary DI / UDI-DI
- 00630414597881 FDA UDI
- 510(k) Number
- K012777 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay 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: Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Atellica IM aTG by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay.
- Elecsys Anti-Tg — Roche Diagnostics Corp. · Class II
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- IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys Anti-Tg — Roche Diagnostics Corp. · Class II
- IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Anti-Tg AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
Cleared under the same submission
K012777 also covers:
- ADVIA Centaur® Systems Calibrator 1 — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems anti-Tg 1, 2 — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTG — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTG — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTG DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® aTG MCM — Siemens Healthcare Diagnostics
- Atellica IM Calibrator 1 — Siemens Healthcare Diagnostics
- Atellica IM aTG — Siemens Healthcare Diagnostics
- Atellica IM aTG DIL — Siemens Healthcare Diagnostics
- Atellica IM aTG MCM — Siemens Healthcare Diagnostics
- Atellica IM aTG 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 112a9c4f-3add-4648-8866-94f170ea6a66 37 fields · synced May 30, 2026