Australia TGA ARTG record

Bacterial infectious disease IVDs

Australia TGA ARTG Registered Device · Australian Rickettsial Reference Laboratory Foundation Ltd · Fuller Laboratories · Class IIa · Started April 28, 2018

Good Name: Australian Rickettsial Reference Laboratory Foundation Ltd - Bacterial infectious disease IVDs

Device classification

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

Registration information

Start Date: April 28, 2018
Effective Date: April 28, 2018

Sponsor

Name: Australian Rickettsial Reference Laboratory Foundation Ltd

Manufacturer

Name: Fuller Laboratories
Country: United States of America
Address: 1312 E Valencia Drive, Fullerton, CA, 92831

Intended purpose

IVDs designed for the detection and semiquantitation of antibodies against Borrelia in human serum or plasma. Laboratory test only.

About this record

Access comprehensive regulatory information for Bacterial infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Australian Rickettsial Reference Laboratory Foundation Ltd, manufactured by Fuller Laboratories in United States of America. The device registration started on April 28, 2018.

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.