Australia TGA ARTG record

Infectious disease IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc · Class I · Started February 28, 2020

Good Name: Abbott Rapid Diagnostics Pty Ltd - Infectious disease IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD-Export

Registration information

Start Date: February 28, 2020
Effective Date: February 28, 2020

Sponsor

Name: Abbott Rapid Diagnostics Pty Ltd

Manufacturer

Name: Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc
Country: United States of America
Address: 10 Southgate Road, Scarborough, Maine, 04074

Intended purpose

IVDs to aid in the diagnosis of infectious diseases.

About this record

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 February 28, 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.