Identity
- Trade Name
- Total Thyroxine (tT4) ELISA FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay FDA UDI
- Model / Reference
- EIA-5279 FDA UDI
- Description
- The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay FDA UDI
Identifiers
- Catalog Number
- EIA-5279 FDA UDI
- Primary DI / UDI-DI
- 00840239052797 FDA UDI
- 510(k) Number
- K971709 FDA UDI
- FDA Product Code
- KLI FDA UDI
- GMDN Term
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)
Total Thyroxine (tT4) ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA).
- T3-Uptake ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- T-4 Total ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- TSH (ultrasensitive) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- T3 Total ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Triiodothyronine (T3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Total Thyroxine (T4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- T-3 — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K971709 also covers:
- Total Thyroxine (tT4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
- T4 AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.
- T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.
- T4 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.
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
- DRG International, Inc.
Sources (1)
- FDA UDI 4c912a9d-e185-4c48-bcd1-53e587c4c565 37 fields · synced Jun 6, 2026