Australia TGA ARTG record

Helicobacter IVDs

Australia TGA ARTG Registered Device · Integrated Sciences Pty Ltd · Seegene Inc · Class IIb · Started January 31, 2023

Good Name: Integrated Sciences Pty Ltd - Helicobacter IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: January 31, 2023
Effective Date: January 31, 2023

Sponsor

Name: Integrated Sciences Pty Ltd

Manufacturer

Name: Seegene Inc
Country: South Korea
Address: Taewon Bldg 91, Ogeum-ro Songpa-gu, Seoul, 05548

Intended purpose

Assay for the qualitative detection of H. pylori and mutations responsible for clarithromycin resistance of H. pylori

About this record

Access comprehensive regulatory information for Helicobacter IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Integrated Sciences Pty Ltd, manufactured by Seegene Inc in South Korea. The device registration started on January 31, 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.