Identity
- Trade Name
- N-T4 AccuBind ELISA Test System - 960 Wells FDA UDI
- Generic Name
- Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 2625-300 FDA UDI
Identifiers
- Catalog Number
- 2625-300E FDA UDI
- Primary DI / UDI-DI
- 00816870021249 FDA UDI
- 510(k) Number
- K030860 FDA UDI
- FDA Product Code
- CDX FDA UDI
- GMDN Term
- Neonatal thyroxine (neonatal T4) 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: Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA)
N-T4 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 Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA).
- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class II
- N-T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- N-T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- N-T4 AccuBind ELISA Test System - 1920 Wells — MONOBIND, INC. · Class II
- N-T4 AccuBind ELISA Test System - 480 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K030860 also covers:
- Free Thyroxine (fT4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- N-T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
- N-T4 AccuBind ELISA Test System - 1920 Wells — MONOBIND, INC.
- N-T4 AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.
- N-T4 AccuBind ELISA Test System - 96 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 |
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Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI 74992616-1619-402c-b8e0-0ce2541d2989 37 fields · synced May 30, 2026