Identity
- Trade Name
- Dimension® Flex® reagent cartridge T4 FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Thyroxine Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10444908 FDA UDI
- Description
- Thyroxine Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- DF65 FDA UDI
- Primary DI / UDI-DI
- 00842768005626 FDA UDI
- 510(k) Number
- K862359 FDA UDI
- FDA Product Code
- CIG FDA UDIKLI FDA UDI
- GMDN Term
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 FDA UDI862.1700 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: Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Dimension® Flex® reagent cartridge T4 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, kit, enzyme immunoassay (EIA).
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- QMedix™ — Diagnostic Automation, Inc. · Class II
- T4 High Sensitivity AccuBind ELISA Test System - 96 wells — MONOBIND, INC. · Class II
- T4 High Sensitivity AccuBind ELISA Test System - 192 wells — MONOBIND, INC. · Class II
- T4 SBS AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- T4 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC. · Class II
- T4 SBS AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K862359 also covers:
- Dimension® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge TU — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge URCA — Siemens Healthcare Diagnostics
- Dimension® T4 Calibrator — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2dda3510-f6e1-4b13-a6f8-d041abb684b7 37 fields · synced Jun 8, 2026