GUDIDData
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eudamed_udi Primary ID: 15099590070588

D-Dimer Control (UDI 15099590070588)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for D-Dimer Control - Primary ID 15099590070588

Device Regulatory Overview

The D-Dimer Control (Model/Catalog Number: ODC0029) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W0102152003 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 →

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only....

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ID: Z-0441-2026 View Full Alert →

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706...

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ID: Z-0032-2026 View Full Alert →

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
ODC0029
Product Code / EMDN
W0102152003
Device Name
D-Dimer Control
Database Sync Date
2026-08-09 16:30:07

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 D-Dimer Control?

The registered manufacturer of record for D-Dimer Control is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for D-Dimer Control?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15099590070588.

What classification code is assigned to this device?

This device is registered under product classification code W0102152003.

Similar Classification Devices (W0102152003)

Other Devices by Beckman Coulter Inc.

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