GUDIDData
eudamed_udi Primary ID: 15099590575045

Access Ferritin Calibrators (UDI 15099590575045)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Access Ferritin Calibrators - Primary ID 15099590575045

Device Regulatory Overview

The Access Ferritin Calibrators (Model/Catalog Number: 33025) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W0102152206 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 →

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

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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
33025
Product Code / EMDN
W0102152206
Device Name
Access Ferritin Calibrators
Database Sync Date
2026-08-09 17:02:10

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 Access Ferritin Calibrators?

The registered manufacturer of record for Access Ferritin Calibrators is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for Access Ferritin Calibrators?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15099590575045.

What classification code is assigned to this device?

This device is registered under product classification code W0102152206.

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