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Escherichia coli (E. coli) IVDs - ARTG 398572

Access comprehensive regulatory information for Escherichia coli (E. coli) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 398572 and sponsored by Integrated Sciences Pty Ltd, manufactured by Seegene Inc in South Korea. The device registration started on October 28, 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.

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TGA ARTG Official Data
Class IIb
ARTG 398572
Class IIb
Escherichia coli (E. coli) IVDs
ARTG ID: 398572
Good Name: Integrated Sciences Pty Ltd - Escherichia coli (E. coli) IVDs
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Intended Purpose

Allplex stx1/2/2a/2d Typing is a qualitative in vitro diagnostic test for the single or multiple detection of Shiga toxin 1 (stx1), Shiga toxin 2 (stx2), Shiga toxin 2a (stx2a) and Shiga toxin 2d (stx2d) of Escherichia coli

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
398572
Start Date
October 28, 2022
Effective Date
October 28, 2022
Manufacturer
Country
South Korea
Address
Taewon Bldg 91, Ogeum-ro Songpa-gu, Seoul, 05548