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Software IVDs - ARTG 388426

Access comprehensive regulatory information for Software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 388426 and sponsored by Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Laboratories (USA) in United States of America. The device registration started on May 13, 2022.

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 388426
Class I
Software IVDs
ARTG ID: 388426
Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Software IVDs
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Intended Purpose

Software intended to influence an IVD Instrument/Analyser

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
388426
Start Date
May 13, 2022
Effective Date
May 13, 2022
Manufacturer
Country
United States of America
Address
4551 Great American Pkwy, Santa Clara, California, 95054