GUDIDData
gudid Primary ID: 03289788160

Elecsys Free PSA Immunoassay (UDI 03289788160)

Manufactured by Roche Diagnostics GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Elecsys Free PSA Immunoassay - Primary ID 03289788160

Device Regulatory Overview

The Elecsys Free PSA Immunoassay (Model/Catalog Number: 03289788160) is a medical device manufactured by Roche Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification MTG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
03289788160
Product Code / EMDN
MTG
Device Name
Database Sync Date
2026-08-09 09:33:50

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 Elecsys Free PSA Immunoassay?

The registered manufacturer of record for Elecsys Free PSA Immunoassay is Roche Diagnostics GmbH.

What is the Primary UDI-DI identifier for Elecsys Free PSA Immunoassay?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03289788160.

What classification code is assigned to this device?

This device is registered under product classification code MTG.

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