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Instrument/analyser IVDs - ARTG 399596

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 399596 and 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.

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Class I
ARTG 399596
Class I
Instrument/analyser IVDs
ARTG ID: 399596
Good Name: Innervate Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

The Bilistick Reader 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.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
399596
Start Date
November 17, 2022
Effective Date
November 17, 2022
Manufacturer
Country
Italy
Address
SS 14 Km 1635 Area Science Park snc Trieste Fraz Basovizza (TS), Italia, 34149