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gudid Primary ID: 11065584

Xprecia Stride Coagulation Analyzer (UDI 11065584)

Manufactured by Siemens Healthcare Diagnostics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Xprecia Stride Coagulation Analyzer - Primary ID 11065584

Device Regulatory Overview

The Xprecia Stride Coagulation Analyzer (Model/Catalog Number: 11065584) is a medical device manufactured by Siemens Healthcare Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification GGN 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-2087-2016 View Full Alert →

Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) ...

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ID: Z-2058-2014 View Full Alert →

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics...

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ID: Z-0459-2016 View Full Alert →

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with ...

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Technical Specifications

Model Number
11065584
Product Code / EMDN
GGN
Device Name
The Xprecia Stride Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.
Database Sync Date
2026-08-09 09:32:41

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 Xprecia Stride Coagulation Analyzer?

The registered manufacturer of record for Xprecia Stride Coagulation Analyzer is Siemens Healthcare Diagnostics Inc..

What is the Primary UDI-DI identifier for Xprecia Stride Coagulation Analyzer?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11065584.

What classification code is assigned to this device?

This device is registered under product classification code GGN.

Similar Classification Devices (GGN)

Other Devices by Siemens Healthcare Diagnostics Inc.

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