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Clinical chemistry-specific protein IVDs - ARTG 291533

Access comprehensive regulatory information for Clinical chemistry-specific protein IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 291533 and sponsored by Abacus dx Pty Ltd, manufactured by Sero AS in Norway. The device registration started on July 14, 2017.

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 IIa
ARTG 291533
Class IIa
Clinical chemistry-specific protein IVDs
ARTG ID: 291533
Good Name: Abacus dx Pty Ltd - Clinical chemistry-specific protein IVDs
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Intended Purpose

IVDs intended to be used as quality control material to monitor laboratory measurement procedures of clinical chemistry specific proteins.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
291533
Start Date
July 14, 2017
Effective Date
July 14, 2017
Manufacturer
Country
Norway
Address
Stasjonsveien 44, Billingstad, N-1375