Australia TGA ARTG record

Neisseria IVDs

Australia TGA ARTG Registered Device · Integrated Sciences Pty Ltd · Seegene Inc · Class IIb · Started September 14, 2022

Good Name: Integrated Sciences Pty Ltd - Neisseria IVDs

Device classification

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

Registration information

Start Date: September 14, 2022
Effective Date: September 14, 2022

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

Allplex NG & DR Assay is a qualitative in vitro diagnostic test for single or multiple detection of N. gonorrhoeae (NG) and the mutation of A2059G and C2611T in the 23S rRNA gene responsible for Azithromycin resistance in N. gonorrhoeae (NG), and S91F in the gyrase A responsible for Ciprofloxacin resistance in N. gonorrhoeae (NG)

About this record

Access comprehensive regulatory information for Neisseria 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 September 14, 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.