GUDIDData
eudamed_udi Primary ID: D-CDX-170-01-20NV

GenomEra HSV 1/2, VZV + EV Assay Kit (UDI D-CDX-170-01-20NV)

Manufactured by Abacus Diagnostica Oy

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GenomEra HSV 1/2, VZV + EV Assay Kit - Primary ID D-CDX-170-01-20NV

Device Regulatory Overview

The GenomEra HSV 1/2, VZV + EV Assay Kit (Model/Catalog Number: CDX-170-01-20) is a medical device manufactured by Abacus Diagnostica Oy. This product is indexed under FDA Product Code / Category Classification W0105070302 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CDX-170-01-20
Product Code / EMDN
W0105070302
Device Name
CDX-170
Database Sync Date
2026-08-09 16:29:10

Full Regulatory Attributes

🔒 Token Gated
{
    "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 HSV 1/2, VZV + EV Assay Kit?

The registered manufacturer of record for GenomEra HSV 1/2, VZV + EV Assay Kit is Abacus Diagnostica Oy.

What is the Primary UDI-DI identifier for GenomEra HSV 1/2, VZV + EV Assay Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CDX-170-01-20NV.

What classification code is assigned to this device?

This device is registered under product classification code W0105070302.

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