Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Medical Co Ltd · Class I · Started August 31, 2016

Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Specimen receptacle IVDs

Device classification

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

Registration information

Start Date: August 31, 2016
Effective Date: August 31, 2016

Sponsor

Name: Abbott Rapid Diagnostics Pty Ltd

Manufacturer

Name: Abbott Diagnostics Medical Co Ltd
Country: Japan
Address: 357 Matsuhidai Matsudo-shi, Chiba, 270-2214

Intended purpose

IVDs intended for the collection and containment of clinical specimens

About this record

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Medical Co Ltd in Japan. The device registration started on August 31, 2016.

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.