GUDIDData
gudid Primary ID: 12825-300

T4 High Sensitivity AccuBind ELISA Test System - 192 wells (UDI 12825-300)

Manufactured by MONOBIND, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for T4 High Sensitivity AccuBind ELISA Test System - 192 wells - Primary ID 12825-300

Device Regulatory Overview

The T4 High Sensitivity AccuBind ELISA Test System - 192 wells (Model/Catalog Number: 12825-300) is a medical device manufactured by MONOBIND, INC.. This product is indexed under FDA Product Code / Category Classification KLI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
12825-300
Product Code / EMDN
KLI
Device Name
Database Sync Date
2026-08-09 09:31:26

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of T4 High Sensitivity AccuBind ELISA Test System - 192 wells?

The registered manufacturer of record for T4 High Sensitivity AccuBind ELISA Test System - 192 wells is MONOBIND, INC..

What is the Primary UDI-DI identifier for T4 High Sensitivity AccuBind ELISA Test System - 192 wells?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 12825-300.

What classification code is assigned to this device?

This device is registered under product classification code KLI.

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