Identity
- Trade Name
- T3 AccuBind ELISA Test System - 192 Wells FDA UDI
- Generic Name
- Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 125-300 FDA UDI
Identifiers
- Catalog Number
- 125-300B FDA UDI
- Primary DI / UDI-DI
- 00816870021546 FDA UDI
- 510(k) Number
- K971779 FDA UDI
- FDA Product Code
- CDP FDA UDI
- GMDN Term
- Total triiodothyronine (TT3) 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
No
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
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
T3 AccuBind ELISA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA).
- Qmedix — Diagnostic Automation, Inc. · Class II
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- Total Triiodothyronine (Total T3) ELISA — American Laboratory Products Company · Class II
- Monobind AccuBind T3 ELISA Kit - 96 Wells — MONOBIND, INC. · Class II
- T3 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC. · Class II
- T3 SBS AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- Monobind AccuBind T3 ELISA Kit - 480 Wells — MONOBIND, INC. · Class II
- T3 SBS AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K971779 also covers:
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Total Triiodothyronine (tT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Total Triiodothyronine (tT3) ELISA — DRG International, Inc.
- Monobind AccuBind T3 ELISA Kit - 480 Wells — MONOBIND, INC.
- Monobind AccuBind T3 ELISA Kit - 96 Wells — MONOBIND, INC.
- T3 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.
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
- Monobind, Inc.
Sources (1)
- FDA UDI 887d1a37-b832-42e4-ad6b-b31c6a7c5a16 37 fields · synced Jun 1, 2026