Identity
- Trade Name
- T4 AccuBind ELISA Test System - 480 Wells FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 225-300 FDA UDI
Identifiers
- Catalog Number
- 225-300D FDA UDI
- Primary DI / UDI-DI
- 00816870021676 FDA UDI
- 510(k) Number
- K971709 FDA UDI
- FDA Product Code
- CDX FDA UDI
- GMDN Term
- Total thyroxine (TT4) 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
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 — 12 Inch FDA UDI
Category: Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
T4 AccuBind ELISA Test System - 480 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA).
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- QMedix™ — Diagnostic Automation, Inc. · Class II
- Total Thyroxine ELISA (Total T4 ELISA) — American Laboratory Products Company · Class II
- Dimension® Flex® reagent cartridge T4 — Siemens Healthcare Diagnostics · Class II
- T4 High Sensitivity AccuBind ELISA Test System - 96 wells — MONOBIND, INC. · Class II
- T4 High Sensitivity AccuBind ELISA Test System - 192 wells — MONOBIND, INC. · Class II
Cleared under the same submission
K971709 also covers:
- Total Thyroxine (tT4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Total Thyroxine (tT4) ELISA — DRG International, Inc.
- T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
- T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.
- T4 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 ce4639a3-e444-4471-aa21-ac9725b88ff3 37 fields · synced May 30, 2026