gudid Primary ID: A031-101

DELFIA hLH Spec kit (UDI A031-101)

Manufactured by Wallac Oy

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

Scannable UDI-DI Representation

Device Regulatory Overview

The DELFIA hLH Spec kit (Model/Catalog Number: A031-101) is a medical device manufactured by Wallac Oy. This product is indexed under FDA Product Code / Category Classification CEP within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: A031-101
Product Code / EMDN: CEP
Device Name: Time-resolved fluoroimmunoassay for the quantitative determination of human luteinizing hormone (hLH).
Database Sync Date: 2026-08-09 09:24:54

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 DELFIA hLH Spec kit?

The registered manufacturer of record for DELFIA hLH Spec kit is Wallac Oy.

What is the Primary UDI-DI identifier for DELFIA hLH Spec kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is A031-101.

What classification code is assigned to this device?

This device is registered under product classification code CEP.

Similar Classification Devices (CEP)

Other Devices by Wallac Oy

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