Australia TGA ARTG record

Viral infectious disease IVDs

Australia TGA ARTG Registered Device · Key Diagnostics Pty Ltd · Microgen Bioproducts Limited · Class IIa · Started July 16, 2015

Good Name: Key Diagnostics Pty Ltd - Viral infectious disease IVDs

Device classification

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

Registration information

Start Date: July 16, 2015
Effective Date: July 16, 2015

Sponsor

Name: Key Diagnostics Pty Ltd

Manufacturer

Name: Microgen Bioproducts Limited
Country: United Kingdom
Address: 1 Admiralty Way, CAMBERLEY , SURREY, GU15 3DT

Intended purpose

CT355 Viral infectious disease IVDs. For rotavirus and adenovirus antigen detection in stool for laboratory use only.

About this record

Access comprehensive regulatory information for Viral infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Key Diagnostics Pty Ltd, manufactured by Microgen Bioproducts Limited in United Kingdom. The device registration started on July 16, 2015.

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.