Identity
- Trade Name
- Free Triiodothyronine (fT3) 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. FDA UDI
- Model / Reference
- EIA-5277 FDA UDI
- Description
- The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay. FDA UDI
Identifiers
- Catalog Number
- EIA-5277 FDA UDI
- Primary DI / UDI-DI
- 04048474052770 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)
Free Triiodothyronine (fT3) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA).
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- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
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Cleared under the same submission
K971779 also covers:
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Total Triiodothyronine (tT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Total Triiodothyronine (tT3) ELISA — DRG International, Inc.
- Monobind AccuBind T3 ELISA Kit - 480 Wells — MONOBIND, INC.
- Monobind AccuBind T3 ELISA Kit - 96 Wells — MONOBIND, INC.
- T3 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
- T3 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 |
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Manufacturer
Sources (1)
- FDA UDI 09146287-dced-4a23-af24-751dd0a0bbb9 37 fields · synced May 30, 2026