gudid Primary ID: FT4 Immunoassay

FastPack IP Free T4 Kit (30) (UDI FT4 Immunoassay)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The FastPack IP Free T4 Kit (30) (Model/Catalog Number: FT4 Immunoassay) is a medical device manufactured by QUALIGEN INC.. This product is indexed under FDA Product Code / Category Classification CEC within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: FT4 Immunoassay
Product Code / EMDN: CEC
Device Name: 30 Test Ported FT4 Immunoassay Kit
Database Sync Date: 2026-08-09 10:01:41

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 FastPack IP Free T4 Kit (30)?

The registered manufacturer of record for FastPack IP Free T4 Kit (30) is QUALIGEN INC..

What is the Primary UDI-DI identifier for FastPack IP Free T4 Kit (30)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FT4 Immunoassay.

What classification code is assigned to this device?

This device is registered under product classification code CEC.

Similar Classification Devices (CEC)

Other Devices by QUALIGEN INC.

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