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Multiple clinical chemistry constituent IVDs

Access comprehensive regulatory information for Multiple clinical chemistry constituent IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Abacus dx Pty Ltd, manufactured by Sero AS in Norway. The device registration started on May 27, 2011.

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
Class IIa
Multiple clinical chemistry constituent IVDs
Australia TGA ARTG Registered Device
Good Name: Abacus dx Pty Ltd - Multiple clinical chemistry constituent IVDs
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Intended Purpose

It is intended for use as an assayed quality control material to verify the precision and trueness of laboratory measurement procedures.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
May 27, 2011
Effective Date
May 27, 2011
Manufacturer
Country
Norway
Address
Stasjonsveien 44, Billingstad, N-1375