ARTG 458113

Treponema (syphilis) IVDs

ARTG ID: 458113 · Southern Cross Diagnostics Pty Ltd · Newmarket Biomedical Ltd · Class IIb · Started August 01, 2024

Good Name: Southern Cross Diagnostics Pty Ltd - Treponema (syphilis) IVDs

Device classification

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

Registration information

ARTG ID: 458113
Start Date: August 01, 2024
Effective Date: August 01, 2024

Sponsor

Name: Southern Cross Diagnostics Pty Ltd

Manufacturer

Name: Newmarket Biomedical Ltd
Country: United Kingdom
Address: Unit 1 Lanwades Business Park, Kentford Newmarket, Suffolk, CB8 7PN

Intended purpose

For the qualitative detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CSF and to determine the titre level of the samples. Not for blood screening or as a confirmatory assay on donor samples.

About this record

Access comprehensive regulatory information for Treponema (syphilis) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 458113 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Newmarket Biomedical Ltd in United Kingdom. The device registration started on August 01, 2024.

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.