Identity
- Trade Name
- ST AIA-PACK FT3 FDA UDI
- Generic Name
- Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14560189210285 FDA UDI
- FDA Product Code
- CDP FDA UDI
- GMDN Term
- Free triiodothyronine (FT3) 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
St Aia-Pack Ft3 by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA).
- Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- Total Triiodothyronine (tT3) ELISA — DRG International, Inc. · Class II
- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 480 Wells — MONOBIND, INC. · Class II
- Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 960 Wells — MONOBIND, INC. · Class II
- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tosoh Corp.
Sources (1)
- FDA UDI a1987303-4c4b-4776-bf3d-dde44280ad31 34 fields · synced May 30, 2026