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Instrument/analyser IVDs - Instrument/analyser IVDs

Access comprehensive regulatory information for Instrument/analyser IVDs - Instrument/analyser 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 July 09, 2014.

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
Instrument/analyser IVDs - Instrument/analyser IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Instrument/analyser IVDs
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Intended Purpose

Instruments intended to be used as in vitro diagnostics.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
July 09, 2014
Effective Date
October 17, 2019
Manufacturer
Country
United States of America
Address
10 Southgate Road, Scarborough, Maine, 04074