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Infectious disease IVDs

Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc in United States of America. The device registration started on September 20, 2019.

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 I
Class I
Infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Infectious disease IVDs
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Intended Purpose

IVDs to aid in the diagnosis of infectious diseases.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD-Export
Registration Information
Start Date
September 20, 2019
Effective Date
September 20, 2019
Manufacturer
Country
United States of America
Address
10 Southgate Road, Scarborough, Maine, 04074