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Viral infectious disease IVDs

Australia TGA ARTG Registered Device · National Serology Reference Laboratory · DiaMex GmbH · Class IIa · Started August 25, 2017

Good Name: National Serology Reference Laboratory - Viral infectious disease IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
Start Date
August 25, 2017
Effective Date
December 06, 2023
Sponsor
Manufacturer
Country
Germany
Address
Siemenstrasse 38, Heidelberg, 69123
Intended purpose

Non assay-specific infectious disease quality control material intended for use with IVDs that detect antigens or antibodies for viral infectious organisms in human plasma or serum samples

About this record

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 August 25, 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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