Australia flagARTG 341378

Constitutional chromosomal disorder IVDs

ARTG ID: 341378 · Southern Cross Diagnostics Pty Ltd · Yourgene Health UK Limited · Class IIb · Started August 12, 2020

Good Name: Southern Cross Diagnostics Pty Ltd - Constitutional chromosomal disorder IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
341378
Start Date
August 12, 2020
Effective Date
September 27, 2021
Sponsor
Manufacturer
Country
United Kingdom
Address
Skelton House Lloyd Street North Manchester Science Park, Manchester, M15 6SH
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.

About this record

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 registered under ARTG number 341378 and 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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