Identity
- Trade Name
- Dimension® Flex® reagent cartridge TU FDA UDI
- Generic Name
- Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA) FDA UDI
- Device Name
- Thyronine Uptake Flex® reagent cartridge, 160 tests FDA UDI
- Model / Reference
- 10444912 FDA UDI
- Description
- Thyronine Uptake Flex® reagent cartridge, 160 tests FDA UDI
Identifiers
- Catalog Number
- DF75A FDA UDI
- Primary DI / UDI-DI
- 00842768005695 FDA UDI
- 510(k) Number
- K862359 FDA UDI
- FDA Product Code
- KHQ FDA UDICIG FDA UDI
- GMDN Term
- Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1715 FDA UDI862.1110 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: Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)
Dimension® Flex® reagent cartridge TU by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA).
- N-TBG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- Monobind AccuBind TBG ELISA Kit - 96 Wells — MONOBIND, INC. · Class II
- N-TBG AccuBind ELISA Test System - 480 Wells — MONOBIND, INC. · Class II
- N-TBG AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- Dimension Vista® Flex® reagent cartridge TU — Siemens Healthcare Diagnostics · 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 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2de2f4f7-17e0-4d3c-b7c0-17181efd4a89 37 fields · synced May 30, 2026