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eudamed_udi Primary ID: D-447710QE

IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent (UDI D-447710QE)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent - Primary ID D-447710QE

Device Regulatory Overview

The IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent (Model/Catalog Number: 447710) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W0102019004 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0071-2026 View Full Alert →

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ID: Z-0441-2026 View Full Alert →

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DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clin...

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Technical Specifications

Model Number
447710
Product Code / EMDN
W0102019004
Device Name
IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent
Database Sync Date
2026-08-09 18:32:11

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 IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent?

The registered manufacturer of record for IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-447710QE.

What classification code is assigned to this device?

This device is registered under product classification code W0102019004.

Similar Classification Devices (W0102019004)

Other Devices by Beckman Coulter Inc.

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