Australia TGA ARTG record

Bacterial infectious disease IVDs

Australia TGA ARTG Registered Device · Australian Rickettsial Reference Laboratory Foundation Ltd · Cortez Diagnostic Inc · Class IIa · Started November 30, 2016

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: November 30, 2016
Effective Date: November 30, 2016

Sponsor

Name: Australian Rickettsial Reference Laboratory Foundation Ltd

Manufacturer

Name: Cortez Diagnostic Inc
Country: United States of America
Address: 21250 Califa St Suite 102 and 116, Woodland Hills , California , 91367

Intended purpose

The Diagnostic Automation/ Cortez Diagnostics, Inc B. burgdorferi IgG/IgM IFA test system is designed for the qualitative and semi-quantitative presumptive detection of antibodies (IgG and IgM) to Borrelia burgdorferi in human serum. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. The testing is performed in the diagnostic laboratory environment. Limitations include possible cross-reaction with other spirochetes.

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 Cortez Diagnostic Inc in United States of America. The device registration started on November 30, 2016.

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.