UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent (UDI D-B24985VM)
Manufactured by Beckman Coulter Inc.
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.
Enforcement actions are currently active for this product line.
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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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Get API Token Access ($49/mo)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.
Similar Classification Devices (W01010213)
Other Devices by Beckman Coulter Inc.
- → SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
- → SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- → 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 Clinical Analyzer
- → UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
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