gudid Primary ID: TSH Immunoassay

FastPack IP TSH Kit (30) (UDI TSH Immunoassay)

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

Scannable UDI-DI Representation

Device Regulatory Overview

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

Technical Specifications

Model Number: TSH Immunoassay
Product Code / EMDN: JLW
Device Name: 30 Test Ported TSH 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 TSH Kit (30)?

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

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

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

What classification code is assigned to this device?

This device is registered under product classification code JLW.

Similar Classification Devices (JLW)

Other Devices by QUALIGEN INC.

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