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Influenza virus IVDs

Access comprehensive regulatory information for Influenza virus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Korea Inc in South Korea. The device registration started on February 21, 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 IIb
Class IIb
Influenza virus IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Influenza virus IVDs
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Intended Purpose

IVDs intended to be used in the testing of clinical specimens to provide information about infection or exposure to influenza virus.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 21, 2019
Effective Date
September 11, 2020
Manufacturer
Country
South Korea
Address
65 Borahagal-ro Giheung-gu Yongin-si Gyeonggi-do, Korea, 17099