Australia TGA ARTG record

Clinical chemistry - Clinical chemistry-specific protein IVDs

Australia TGA ARTG Registered Device · Qiagen Pty Ltd · QIAGEN Sciences LLC · Class IIa · Started November 10, 2015

Good Name: Qiagen Pty Ltd - Clinical chemistry-specific protein IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: November 10, 2015
Effective Date: March 08, 2019

Sponsor

Name: Qiagen Pty Ltd

Manufacturer

Name: QIAGEN Sciences LLC
Country: United States of America
Address: 19300 Germantown Road, Germantown, MD, 20874

Intended purpose

Tests to be used for the qualitative and/or quantitative detection of proteins specific to clinical chemistry in a clinical specimen.

About this record

Access comprehensive regulatory information for Clinical chemistry - Clinical chemistry-specific protein IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Qiagen Pty Ltd, manufactured by QIAGEN Sciences LLC in United States of America. The device registration started on November 10, 2015.

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.