Identity
- Trade Name
- Free Triiodothyronine (fT3) ELISA FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum FDA UDI
- Model / Reference
- EIA-2385 FDA UDI
- Description
- For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum FDA UDI
Identifiers
- Catalog Number
- EIA-2385 FDA UDI
- Primary DI / UDI-DI
- 00840239023858 FDA UDI
- FDA Product Code
- CDP FDA UDI
- GMDN Term
- Multiple thyroid marker 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
Yes
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)
Free Triiodothyronine (fT3) 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
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 4939bd6d-ebc7-4dad-832b-5415f99cc7f1 36 fields · synced Jun 1, 2026