GUDIDData
eudamed_udi Primary ID: D-B24985VM

UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent (UDI D-B24985VM)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent - Primary ID D-B24985VM

Device Regulatory Overview

The UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent (Model/Catalog Number: B24985) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W01010213 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
B24985
Product Code / EMDN
W01010213
Device Name
UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent
Database Sync Date
2026-08-09 16:28:51

Full Regulatory Attributes

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{
    "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 UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent?

The registered manufacturer of record for UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-B24985VM.

What classification code is assigned to this device?

This device is registered under product classification code W01010213.

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