Identity
- Trade Name
- Dimension® T4 Calibrator FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, calibrator FDA UDI
- Device Name
- Thyroxine Calibrator, 2x5x1mL, reconstituted FDA UDI
- Model / Reference
- 10445029 FDA UDI
- Description
- Thyroxine Calibrator, 2x5x1mL, reconstituted FDA UDI
Identifiers
- Catalog Number
- DC13 FDA UDI
- Primary DI / UDI-DI
- 00842768004919 FDA UDI
- 510(k) Number
- K862359 FDA UDI
- FDA Product Code
- CIG FDA UDIJIT FDA UDI
- GMDN Term
- Total thyroxine (TT4) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 FDA UDI862.1150 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
Yes
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: Total thyroxine (TT4) IVD, calibrator
Dimension® T4 Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total thyroxine (TT4) IVD, calibrator.
- Elecsys CalSet T4 — Roche Diagnostics Corp. · Class II
- Alinity — ABBOTT IRELAND · Class II
- ARCHITECT — ABBOTT IRELAND · Class I
- ACE — Alfa Wassermann, Inc. · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
Cleared under the same submission
K862359 also covers:
- Dimension® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge T4 — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge TU — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge URCA — Siemens Healthcare Diagnostics
- Dimension® TU Calibrator — 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 0634eb6a-8bf4-436f-b1f1-942d60f56b05 37 fields · synced May 30, 2026