Australia TGA ARTG record

Bilirubin IVDs

Australia TGA ARTG Registered Device · Innervate Pty Ltd · BILIMETRIX Srl · Class IIb · Started November 17, 2022

Good Name: Innervate Pty Ltd - Bilirubin IVDs

Device classification

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

Registration information

Start Date: November 17, 2022
Effective Date: November 17, 2022

Sponsor

Name: Innervate Pty Ltd

Manufacturer

Name: BILIMETRIX Srl
Country: Italy
Address: SS 14 Km 1635 Area Science Park snc Trieste Fraz Basovizza (TS), Italia, 34149

Intended purpose

The Bilistick System is an in vitro diagnostic assay intended to quantitatively measure neonatal bilirubin in whole blood (serum) to aid in assessing the risk of kernicterus in neonates. It is intended for use by health professionals, near patient or at a point-of-care setting.

About this record

Access comprehensive regulatory information for Bilirubin IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Innervate Pty Ltd, manufactured by BILIMETRIX Srl in Italy. The device registration started on November 17, 2022.

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.