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 Integrated Sciences Pty Ltd, manufactured by Dynex Technologies Inc in United States of America. The device registration started on April 19, 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.

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: Integrated Sciences Pty Ltd - Instrument/analyser IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Analyser for the processing of clinicial samples by ELISA

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
April 19, 2022
Effective Date
April 19, 2022
Manufacturer
Country
United States of America
Address
14340 Sullyfield Circle, Chantilly, VA, 20151