eudamed_udi Primary ID: D-CDX-40-01-20TX

GenomEra® C. difficile Assay Kit (UDI D-CDX-40-01-20TX)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The GenomEra® C. difficile Assay Kit (Model/Catalog Number: CDX-40-01-20) is a medical device manufactured by Abacus Diagnostica Oy. This product is indexed under FDA Product Code / Category Classification W0105011804 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: CDX-40-01-20
Product Code / EMDN: W0105011804
Device Name: CDX-40
Database Sync Date: 2026-08-09 16:46:58

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 GenomEra® C. difficile Assay Kit?

The registered manufacturer of record for GenomEra® C. difficile Assay Kit is Abacus Diagnostica Oy.

What is the Primary UDI-DI identifier for GenomEra® C. difficile Assay Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CDX-40-01-20TX.

What classification code is assigned to this device?

This device is registered under product classification code W0105011804.

Similar Classification Devices (W0105011804)

Other Devices by Abacus Diagnostica Oy

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