GUDIDData
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eudamed_udi Primary ID: D-B36415UY

Hemoglobin A1c Reagent (HbA1c3 250) (UDI D-B36415UY)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Hemoglobin A1c Reagent (HbA1c3 250) - Primary ID D-B36415UY

Device Regulatory Overview

The Hemoglobin A1c Reagent (HbA1c3 250) (Model/Catalog Number: B36415) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W01010214 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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πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-0441-2026 View Full Alert →

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

πŸ”’ Compromised Lot & Serial Numbers Locked
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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...

πŸ”’ Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
B36415
Product Code / EMDN
W01010214
Device Name
Hemoglobin A1c Reagent (HbA1c3 250)
Database Sync Date
2026-08-09 16:49:46

Full Regulatory Attributes

πŸ”’ 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 Hemoglobin A1c Reagent (HbA1c3 250)?

The registered manufacturer of record for Hemoglobin A1c Reagent (HbA1c3 250) is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for Hemoglobin A1c Reagent (HbA1c3 250)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-B36415UY.

What classification code is assigned to this device?

This device is registered under product classification code W01010214.

Similar Classification Devices (W01010214)

Other Devices by Beckman Coulter Inc.

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