gudid Primary ID: 675-300

Monobind AccuLite LH CLIA Kit - 96 Wells (UDI 675-300)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Monobind AccuLite LH CLIA Kit - 96 Wells (Model/Catalog Number: 675-300) is a medical device manufactured by MONOBIND, INC.. This product is indexed under FDA Product Code / Category Classification CEP within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 675-300
Product Code / EMDN: CEP
Device Name
Database Sync Date: 2026-08-09 09:31:26

Full Regulatory Attributes

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{
    "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 Monobind AccuLite LH CLIA Kit - 96 Wells?

The registered manufacturer of record for Monobind AccuLite LH CLIA Kit - 96 Wells is MONOBIND, INC..

What is the Primary UDI-DI identifier for Monobind AccuLite LH CLIA Kit - 96 Wells?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 675-300.

What classification code is assigned to this device?

This device is registered under product classification code CEP.

Similar Classification Devices (CEP)

Other Devices by MONOBIND, INC.

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