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Multiple clinical chemistry constituent IVDs - ARTG 208662

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 registered under ARTG number 208662 and sponsored by Specialty Diagnostix Pty Ltd, manufactured by Techno-path Manufacturing Ltd in Ireland. The device registration started on April 23, 2013.

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 208662
Class IIa
Multiple clinical chemistry constituent IVDs
ARTG ID: 208662
Good Name: Specialty Diagnostix Pty Ltd - Multiple clinical chemistry constituent IVDs
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Intended Purpose

IVDs intended to be used for the qualitative and/or quantitative determination of multiple analytes (chemical, biological, and/or immunological) from more than one clinical chemistry specialty, in a clinical specimen.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
208662
Start Date
April 23, 2013
Effective Date
April 23, 2013
Manufacturer
Country
Ireland
Address
Fort Henry Business Park Ballina, Co Tipperary