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Constitutional chromosomal disorder IVDs - ARTG 372317

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 372317 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Yourgene Health UK Limited in United Kingdom. The device registration started on August 06, 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.

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Class IIb
ARTG 372317
Class IIb
Constitutional chromosomal disorder IVDs
ARTG ID: 372317
Good Name: Southern Cross Diagnostics Pty Ltd - Constitutional chromosomal disorder IVDs
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Intended Purpose

For the routine in vitro quantitative diagnosis of chromosomal abnormalities of a constitutional nature.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
372317
Start Date
August 06, 2021
Effective Date
August 06, 2021
Manufacturer
Country
United Kingdom
Address
Skelton House Lloyd Street North Manchester Science Park, Manchester, M15 6SH