Australia TGA ARTG record

Severe acute respiratory syndrome-associated coronavirus IVDs

Australia TGA ARTG Registered Device · Qiagen Pty Ltd · NeuMoDx Molecular Inc · Class IIb · Started September 10, 2020

Good Name: Qiagen Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs

Device classification

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

Registration information

Start Date: September 10, 2020
Effective Date: January 18, 2023

Sponsor

Name: Qiagen Pty Ltd

Manufacturer

Name: NeuMoDx Molecular Inc
Country: United States of America
Address: 1250 Eisenhower Place, Ann Arbor, Michigan, 48108

Intended purpose

IVDs for the qualitative detection of SARS-CoV-2 coronavirus RNA from human clinical specimens

About this record

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus 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 September 10, 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.