Australia TGA ARTG record

Multiple infectious organism IVDs

Australia TGA ARTG Registered Device · National Serology Reference Laboratory · Techno-path Manufacturing Ltd · Class IIa · Started May 06, 2020

Good Name: National Serology Reference Laboratory - Multiple infectious organism IVDs

Device classification

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

Registration information

Start Date: May 06, 2020
Effective Date: May 06, 2020

Sponsor

Name: National Serology Reference Laboratory

Manufacturer

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

Intended purpose

Non assay-specific infectious disease quality control material intended for use with IVDs that detect antigens or antibodies for multiple infectious organisms in human plasma or serum samples.

About this record

Access comprehensive regulatory information for Multiple infectious organism IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by National Serology Reference Laboratory, manufactured by Techno-path Manufacturing Ltd in Ireland. The device registration started on May 06, 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.