Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Pharma Soul Holdings Pty Ltd · iXensor Co Ltd · Class I · Started September 14, 2021

Good Name: Pharma Soul Holdings Pty Ltd - Instrument/analyser IVDs

Device classification

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

Registration information

Start Date: September 14, 2021
Effective Date: September 14, 2021

Sponsor

Name: Pharma Soul Holdings Pty Ltd

Manufacturer

Name: iXensor Co Ltd
Country: Taiwan
Address: 6F No 9 Aly 2 Ln 35 Jihu Rd, Neihu Dist, Taipei City, 11492

Intended purpose

The PixoTest® POCT Analyser is intended to be used in conjunction with the PixoTest® COVID-19 Ag Test Kit to digitally display the qualitative measurement of specific antigens to SARS-CoV-2 present in human nasopharynx cavity. This analyser is intended to be used as an aid to early detection of SARS-CoV-2. It provides only an initial screening test result. This product is intended for medical professional use only. The interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.

About this record

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 Pharma Soul Holdings Pty Ltd, manufactured by iXensor Co Ltd in Taiwan. The device registration started on September 14, 2021.

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.