Australia TGA ARTG record

Multiple clinical chemistry constituent IVDs

Australia TGA ARTG Registered Device · Specialty Diagnostix Pty Ltd · Techno-path Manufacturing Ltd · Class IIa · Started April 23, 2013

Good Name: Specialty Diagnostix Pty Ltd - Multiple clinical chemistry constituent IVDs

Device classification

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

Registration information

Start Date: April 23, 2013
Effective Date: April 23, 2013

Sponsor

Name: Specialty Diagnostix Pty Ltd

Manufacturer

Name: Techno-path Manufacturing Ltd
Country: Ireland
Address: Fort Henry Business Park Ballina, Co Tipperary

Intended purpose

IVDs intended to be used for the qualitative and/or quantitative determination of multiple analytes (chemical, biological, and/or immunological) from more than one clinical chemistry specialty, in a clinical specimen.

About this record

Access comprehensive regulatory information for Multiple clinical chemistry constituent IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Specialty Diagnostix Pty Ltd, manufactured by Techno-path Manufacturing Ltd in Ireland. The device registration started on April 23, 2013.

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.