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Clinical chemistry - Clinical chemistry-specific protein IVDs

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.

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Class IIa
Class IIa
Clinical chemistry - Clinical chemistry-specific protein IVDs
Australia TGA ARTG Registered Device
Good Name: Qiagen Pty Ltd - Clinical chemistry-specific protein IVDs
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Intended Purpose

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

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
Manufacturer
Country
United States of America
Address
19300 Germantown Road, Germantown, MD, 20874