Identity
- Trade Name
- T-3 FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3 FDA UDI
- Model / Reference
- HYE-5697 FDA UDI
- Description
- The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3 FDA UDI
Identifiers
- Catalog Number
- HYE-5697 FDA UDI
- Primary DI / UDI-DI
- 04048474056976 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)
T-3 by DRG Instruments Gesellschaft mit beschränkter Haftung — 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).
- Free T3 ELISA — DRG International, Inc. · Class II
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- T3-Uptake ELISA — DRG International, Inc. · Class II
- T-4 Total ELISA — DRG International, Inc. · Class II
- T-3 — DRG International, Inc. · Class II
- Thyroid Stimulating Hormone (TSH) ELISA — DRG International, Inc. · Class II
- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
- Total Thyroxine (tT4) ELISA — DRG International, Inc. · 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
Sources (1)
- FDA UDI ef8ba528-91d3-4e29-b8ae-ad05e2c2c5a5 36 fields · synced May 30, 2026