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Clinical chemistry-specific protein IVDs - ARTG 405656

Access comprehensive regulatory information for Clinical chemistry-specific protein IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 405656 and sponsored by Qiagen Pty Ltd, manufactured by QIAGEN Sciences LLC in United States of America. The device registration started on March 03, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
ARTG 405656
Class IIb
Clinical chemistry-specific protein IVDs
ARTG ID: 405656
Good Name: Qiagen Pty Ltd - Clinical chemistry-specific protein IVDs
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Intended Purpose

IVDs for the qualitative detection of interferon-gamma for assessing cell-mediated immune (CMI) responses

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
405656
Start Date
March 03, 2023
Effective Date
March 03, 2023
Sponsor
Manufacturer
Country
United States of America
Address
19300 Germantown Road, Germantown, MD, 20874