GUDIDData
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eudamed_udi Primary ID: 15099590210717

Access sTfR QC2 & QC3 (UDI 15099590210717)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Access sTfR QC2 & QC3 - Primary ID 15099590210717

Device Regulatory Overview

The Access sTfR QC2 & QC3 (Model/Catalog Number: B11057) 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 →

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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
B11057
Product Code / EMDN
W0102152206
Device Name
Access sTfR QC2 & QC3
Database Sync Date
2026-08-09 18:24:55

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 sTfR QC2 & QC3?

The registered manufacturer of record for Access sTfR QC2 & QC3 is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for Access sTfR QC2 & QC3?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15099590210717.

What classification code is assigned to this device?

This device is registered under product classification code W0102152206.

Similar Classification Devices (W0102152206)

Other Devices by Beckman Coulter Inc.

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