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Multiple-bacteria IVDs

Access comprehensive regulatory information for Multiple-bacteria 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 February 13, 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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TGA ARTG Official Data
Class IIb
Class IIb
Multiple-bacteria IVDs
Australia TGA ARTG Registered Device
Good Name: Qiagen Pty Ltd - Multiple-bacteria IVDs
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Intended Purpose

IVD's for the detection and differentiation of Chlamydia trachomatis and/or Neisseria gonorrhoeae infection in human clinical specimens

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 13, 2020
Effective Date
February 13, 2020
Sponsor
Manufacturer
Country
United States of America
Address
1250 Eisenhower Place, Ann Arbor, Michigan, 48108