Identity
- Trade Name
- T3 free FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine (T3) in serum and EDTA plasma. Only for use with the DRG:HYBRiD-XL Analyzer. FDA UDI
- Model / Reference
- HYE-5356 FDA UDI
- Description
- The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine (T3) in serum and EDTA plasma. Only for use with the DRG:HYBRiD-XL Analyzer. FDA UDI
Identifiers
- Catalog Number
- HYE-5356 FDA UDI
- Primary DI / UDI-DI
- 00840239053565 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)
T3 free 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 85241cc6-a3eb-4e93-bcf1-70ba3896ebb3 36 fields · synced May 30, 2026