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Red and white cell metabolic enzyme and haemolysis IVDs - ARTG 480911

Access comprehensive regulatory information for Red and white cell metabolic enzyme and haemolysis IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 480911 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Sentinel CH SpA in Italy. The device registration started on February 26, 2025.

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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TGA ARTG Official Data
Class IIa
ARTG 480911
Class IIa
Red and white cell metabolic enzyme and haemolysis IVDs
ARTG ID: 480911
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Red and white cell metabolic enzyme and haemolysis IVDs
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Intended Purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6P-DH) in clinical specimen.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
480911
Start Date
February 26, 2025
Effective Date
February 26, 2025
Manufacturer
Country
Italy
Address
Via Robert Koch 2, Milan, 20152