Australia TGA ARTG record

General laboratoryware IVDs

Australia TGA ARTG Registered Device · Key Diagnostics Pty Ltd · Hardy Diagnostics · Class I · Started July 01, 2015

Good Name: Key Diagnostics Pty Ltd - General laboratoryware IVDs

Device classification

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

Registration information

Start Date: July 01, 2015
Effective Date: July 01, 2015

Sponsor

Name: Key Diagnostics Pty Ltd

Manufacturer

Name: Hardy Diagnostics
Country: United States of America
Address: 1430 West McCoy Lane, Santa Maria, CA, 93455

Intended purpose

CT1261 Microbial Isolate Identification and Testing IVDs. These are general culture confirmation tests for microbiology testing based upon chemical reactions such as indole, oxidase and carbohydrate utilisation.

About this record

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Key Diagnostics Pty Ltd, manufactured by Hardy Diagnostics in United States of America. The device registration started on July 01, 2015.

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.