Australia TGA ARTG record

Multiple clinical chemistry constituent IVDs

Australia TGA ARTG Registered Device · Abbott Australasia Pty Ltd Diagnostic Division · Abbott Ireland Diagnostics Division · Class IIa · Started March 24, 2022

Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Multiple clinical chemistry constituent IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: March 24, 2022
Effective Date: March 24, 2022

Sponsor

Name: Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Name: Abbott Ireland Diagnostics Division
Country: Ireland
Address: Finisklin Business Park, SLIGO

Intended purpose

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.

About this record

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 sponsored by Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Ireland Diagnostics Division in Ireland. The device registration started on March 24, 2022.

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.