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Multiple infectious organism IVDs - ARTG 335888

Access comprehensive regulatory information for Multiple infectious organism IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 335888 and sponsored by National Serology Reference Laboratory, manufactured by Techno-path Manufacturing Ltd in Ireland. The device registration started on May 06, 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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Class IIa
ARTG 335888
Class IIa
Multiple infectious organism IVDs
ARTG ID: 335888
Good Name: National Serology Reference Laboratory - Multiple infectious organism IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
335888
Start Date
May 06, 2020
Effective Date
May 06, 2020
Manufacturer
Country
Ireland
Address
Fort Henry Business Park Ballina, Co Tipperary