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Constitutional chromosomal disorder IVDs

Access comprehensive regulatory information for Constitutional chromosomal disorder IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Yourgene Health UK Limited in United Kingdom. The device registration started on August 12, 2020.

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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Class IIb
Class IIb
Constitutional chromosomal disorder IVDs
Australia TGA ARTG Registered Device
Good Name: Southern Cross Diagnostics Pty Ltd - Constitutional chromosomal disorder IVDs
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Intended Purpose

Next generation DNA sequencing (NGS) in-vitro diagnostics intended to be used for human genetic testing including fetal aneuploidies and/or other prenatal and postnatal genetic anomalies.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
August 12, 2020
Effective Date
September 27, 2021
Manufacturer
Country
United Kingdom
Address
Skelton House Lloyd Street North Manchester Science Park, Manchester, M15 6SH