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Hepatitis B virus IVDs

Access comprehensive regulatory information for Hepatitis B virus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Qiagen Pty Ltd, manufactured by NeuMoDx Molecular Inc in United States of America. The device registration started on January 24, 2020.

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
Class IIb
Hepatitis B virus IVDs
Australia TGA ARTG Registered Device
Good Name: Qiagen Pty Ltd - Hepatitis B virus IVDs
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Intended Purpose

IVDs for the quantitation of Hepatitis B virus (HBV) DNA in human clinical specimens.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
January 24, 2020
Effective Date
November 27, 2020
Sponsor
Manufacturer
Country
United States of America
Address
1250 Eisenhower Place, Ann Arbor, Michigan, 48108