Identity
- Trade Name
- Triiodothyronine (T3) ELISA FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- This Triiodothyronine (T3) ELISA is intended for the quantitative determination of triiodothyronine (T3) concentration in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. FDA UDI
- Model / Reference
- EIA-1780 FDA UDI
- Description
- This Triiodothyronine (T3) ELISA is intended for the quantitative determination of triiodothyronine (T3) concentration in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. FDA UDI
Identifiers
- Catalog Number
- EIA-1780 FDA UDI
- Primary DI / UDI-DI
- 00840239017802 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
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)
Triiodothyronine (T3) 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 f0b0c469-cd1d-4e84-9220-32b38bd51d54 36 fields · synced Jun 8, 2026