Identity
- Trade Name
- Total Thyroxine (T4) ELISA FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. FDA UDI
- Model / Reference
- EIA-1781 FDA UDI
- Description
- For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. FDA UDI
Identifiers
- Catalog Number
- EIA-1781 FDA UDI
- Primary DI / UDI-DI
- 04048474017816 FDA UDI
- 510(k) Number
- K991432 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 (T4) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — 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).
- Free T3 ELISA — DRG International, Inc. · Class II
- Triiodothyronine (T3) ELISA — DRG International, Inc. · Class II
- T3-Uptake ELISA — DRG International, Inc. · Class II
- T-4 Total ELISA — DRG International, Inc. · Class II
- T-3 — DRG International, Inc. · Class II
- Thyroid Stimulating Hormone (TSH) ELISA — DRG International, Inc. · Class II
- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
- Total Thyroxine (tT4) ELISA — DRG International, Inc. · Class II
Cleared under the same submission
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
Sources (1)
- FDA UDI b7ce936c-283a-4c21-a6fe-f6617c07cc81 37 fields · synced May 30, 2026