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Clinical chemistry therapeutic drug monitoring IVDs - ARTG 463246

Access comprehensive regulatory information for Clinical chemistry therapeutic drug monitoring IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 463246 and sponsored by Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Ireland Diagnostics Division in Ireland. The device registration started on October 01, 2024.

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 IIb
ARTG 463246
Class IIb
Clinical chemistry therapeutic drug monitoring IVDs
ARTG ID: 463246
Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Clinical chemistry therapeutic drug monitoring IVDs
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Intended Purpose

The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
463246
Start Date
October 01, 2024
Effective Date
October 01, 2024
Manufacturer
Country
Ireland
Address
Finisklin Business Park, SLIGO