Identity
- Trade Name
- Free T3 AccuBind ELISA Test System - 960 Wells FDA UDI
- Generic Name
- Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 1325-300 FDA UDI
Identifiers
- Catalog Number
- 1325-300E FDA UDI
- Primary DI / UDI-DI
- 00816870021645 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
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
Yes
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: Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
Free T3 AccuBind ELISA Test System - 960 Wells by Monobind, Inc. — 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).
- Total Triiodothyronine (tT3) ELISA — DRG International, Inc. · Class II
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- Free Triiodothyronine (fT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- ST AIA-PACK FT3 — Tosoh Corp. · Class II
- Total Triiodothyronine (tT3) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Free Triiodothyronine (fT3) ELISA — 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
- Monobind, Inc.
Sources (1)
- FDA UDI b6112c57-9a35-4840-afe5-957b1b7a2ee1 36 fields · synced Jun 1, 2026