Pure Global

Instrument/analyser IVDs

Access comprehensive regulatory information for 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 Korea Inc in South Korea. The device registration started on September 26, 2023.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Instrument/analyser IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Rapid Diagnostics Pty Ltd - Instrument/analyser IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Analysers intended to be used as in vitro diagnostic medical devices

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD-Export
Registration Information
Start Date
September 26, 2023
Effective Date
September 26, 2023
Manufacturer
Country
South Korea
Address
65 Borahagal-ro Giheung-gu Yongin-si Gyeonggi-do, Korea, 17099