Australia TGA ARTG record

Clinical Chemistry IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Medical Co Ltd · Class I · Started December 06, 2019

Good Name: Abbott Rapid Diagnostics Pty Ltd - Clinical Chemistry IVDs

Device classification

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

Registration information

Start Date: December 06, 2019
Effective Date: December 06, 2019

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

Rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) for early detection of pregnancy.

About this record

Access comprehensive regulatory information for Clinical Chemistry 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 December 06, 2019.

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.