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Infectious disease IVDs - ARTG 330558

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 registered under ARTG number 330558 and 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.

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TGA ARTG Official Data
Class I
ARTG 330558
Class I
Infectious disease IVDs
ARTG ID: 330558
Good Name: Abbott Rapid Diagnostics Pty Ltd - 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
ARTG ID
330558
Start Date
February 28, 2020
Effective Date
February 28, 2020
Manufacturer
Country
United States of America
Address
10 Southgate Road, Scarborough, Maine, 04074