gudid Primary ID: U211-101

MISSION U500 URINE ANALYZER (UDI U211-101)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The MISSION U500 URINE ANALYZER (Model/Catalog Number: U211-101) is a medical device manufactured by Acon Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification KQO within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2322-2015 View Full Alert →

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the...

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Technical Specifications

Model Number: U211-101
Product Code / EMDN: KQO
Device Name: URINE ANALYZER
Database Sync Date: 2026-08-09 10:01:48

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 MISSION U500 URINE ANALYZER?

The registered manufacturer of record for MISSION U500 URINE ANALYZER is Acon Laboratories, Inc..

What is the Primary UDI-DI identifier for MISSION U500 URINE ANALYZER?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U211-101.

What classification code is assigned to this device?

This device is registered under product classification code KQO.

Similar Classification Devices (KQO)

Other Devices by Acon Laboratories, Inc.

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