gudid Primary ID: 5083-0003-00

ARK Ketamine II Control (25/75) (UDI 5083-0003-00)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ARK Ketamine II Control (25/75) (Model/Catalog Number: 5083-0003-00) is a medical device manufactured by ARK DIAGNOSTICS INC. This product is indexed under FDA Product Code / Category Classification LAS within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 5083-0003-00
Product Code / EMDN: LAS
Device Name: The ARK Ketamine II Control is intended for use in quality control of the ARK Ketamine II Assay.
Database Sync Date: 2026-08-09 09:22:10

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 Ketamine II Control (25/75)?

The registered manufacturer of record for ARK Ketamine II Control (25/75) is ARK DIAGNOSTICS INC.

What is the Primary UDI-DI identifier for ARK Ketamine II Control (25/75)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5083-0003-00.

What classification code is assigned to this device?

This device is registered under product classification code LAS.

Similar Classification Devices (LAS)

Other Devices by ARK DIAGNOSTICS INC

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