Identity
- Trade Name
- Total Triiodothyronine (tT3) ELISA FDA UDI
- Generic Name
- Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay. Levels of fT3 are thought to reflect the amount of T3 available to the cells and may therefore determine the clinical metabolic status of T3. FDA UDI
- Model / Reference
- EIA-5275 FDA UDI
- Description
- The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay. Levels of fT3 are thought to reflect the amount of T3 available to the cells and may therefore determine the clinical metabolic status of T3. FDA UDI
Identifiers
- Catalog Number
- EIA-5275 FDA UDI
- Primary DI / UDI-DI
- 00840239052759 FDA UDI
- 510(k) Number
- K971779 FDA UDI
- FDA Product Code
- CDP FDA UDI
- GMDN Term
- Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1710 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: Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
Total Triiodothyronine (tT3) ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Total Triiodothyronine (tT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K971779 also covers:
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Total Triiodothyronine (tT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
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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
- DRG International, Inc.
Sources (1)
- FDA UDI 76dcced2-b675-4263-b8fd-6876fd5ad8a0 37 fields · synced Jun 8, 2026