Identity
- Trade Name
- T-4 Total ELISA FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG T4 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total Thyroxin (T4) in serum or plasma (EDTA, lithium heparin or citrate plasma). FDA UDI
- Model / Reference
- EIA-4568 FDA UDI
- Description
- The DRG T4 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total Thyroxin (T4) in serum or plasma (EDTA, lithium heparin or citrate plasma). FDA UDI
Identifiers
- Catalog Number
- EIA-4568 FDA UDI
- Primary DI / UDI-DI
- 00840239045683 FDA UDI
- FDA Product Code
- CDX 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
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)
T-4 Total 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 9e0e0e74-6a7c-46e7-99be-3fcf6625a58b 36 fields · synced Jun 8, 2026