gudid Primary ID: 34-2341-21

ImmunoCAP Specific IgE Control M (UDI 34-2341-21)

Manufactured by Phadia AB

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ImmunoCAP Specific IgE Control M (Model/Catalog Number: 34-2341-21) is a medical device manufactured by Phadia AB. This product is indexed under FDA Product Code / Category Classification DHB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 34-2341-21
Product Code / EMDN: DHB
Device Name: ImmunoCAP Specific IgE Control M
Database Sync Date: 2026-08-09 09:48:59

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 ImmunoCAP Specific IgE Control M?

The registered manufacturer of record for ImmunoCAP Specific IgE Control M is Phadia AB.

What is the Primary UDI-DI identifier for ImmunoCAP Specific IgE Control M?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 34-2341-21.

What classification code is assigned to this device?

This device is registered under product classification code DHB.

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