Australia TGA ARTG record

BK virus IVDs

Australia TGA ARTG Registered Device · Diagnostic Technology Pty Ltd · altona Diagnostics GmbH · Class IIb · Started January 10, 2022

Good Name: Diagnostic Technology Pty Ltd - BK virus IVDs

Device classification

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

Registration information

Start Date: January 10, 2022
Effective Date: January 10, 2022

Sponsor

Name: Diagnostic Technology Pty Ltd

Manufacturer

Name: altona Diagnostics GmbH
Country: Germany
Address: Morkenstrasse 12, Hamburg, 22767

Intended purpose

IVD's for the detection and quantification of BK virus specific DNA in human biological samples.

About this record

Access comprehensive regulatory information for BK virus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Diagnostic Technology Pty Ltd, manufactured by altona Diagnostics GmbH in Germany. The device registration started on January 10, 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.