gudid Primary ID: 10445090

Dimension Vista System TPSA Flex Reagent Cartridge (UDI 10445090)

Manufactured by Siemens Healthcare Diagnostics Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Dimension Vista System TPSA Flex Reagent Cartridge (Model/Catalog Number: 10445090) is a medical device manufactured by Siemens Healthcare Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification MTF 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) ...

🔒 Compromised Lot & Serial Numbers Locked

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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: 10445090
Product Code / EMDN: MTF
Device Name: Total Prostate Specific Antigen Flex reagent cartridge 120 Test
Database Sync Date: 2026-08-09 09:13:52

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 Dimension Vista System TPSA Flex Reagent Cartridge?

The registered manufacturer of record for Dimension Vista System TPSA Flex Reagent Cartridge is Siemens Healthcare Diagnostics Inc..

What is the Primary UDI-DI identifier for Dimension Vista System TPSA Flex Reagent Cartridge?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10445090.

What classification code is assigned to this device?

This device is registered under product classification code MTF.

Similar Classification Devices (MTF)

Other Devices by Siemens Healthcare Diagnostics Inc.

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