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Viral infectious disease IVDs

Access comprehensive regulatory information for Viral infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by National Serology Reference Laboratory, manufactured by DiaMex GmbH in Germany. The device registration started on March 23, 2020.

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
Class IIa
Viral infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: National Serology Reference Laboratory - Viral infectious disease IVDs
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Intended Purpose

Non assay-specific viral infectious disease quality control material intended to detect viral DNA/RNA in serum/plasma and other human samples

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
March 23, 2020
Effective Date
September 21, 2022
Manufacturer
Country
Germany
Address
Siemenstrasse 38, Heidelberg, 69123