gudid Primary ID: 5015-0001-00

ARK Topiramate Assay (UDI 5015-0001-00)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ARK Topiramate Assay (Model/Catalog Number: 5015-0001-00) is a medical device manufactured by ARK DIAGNOSTICS INC. This product is indexed under FDA Product Code / Category Classification NWM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 5015-0001-00
Product Code / EMDN: NWM
Device Name: The ARK Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
Database Sync Date: 2026-08-09 09:49:22

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 ARK Topiramate Assay?

The registered manufacturer of record for ARK Topiramate Assay is ARK DIAGNOSTICS INC.

What is the Primary UDI-DI identifier for ARK Topiramate Assay?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5015-0001-00.

What classification code is assigned to this device?

This device is registered under product classification code NWM.

Similar Classification Devices (NWM)

Other Devices by ARK DIAGNOSTICS INC

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