Australia TGA ARTG record

Clinical chemistry biological screening IVDs

Australia TGA ARTG Registered Device · Elitechgroup Australia Pty Ltd · Kova International · Class IIa · Started October 28, 2013

Good Name: Elitechgroup Australia PTY LTD - Clinical chemistry biological screening IVDs

Device classification

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

Registration information

Start Date: October 28, 2013
Effective Date: October 28, 2013

Sponsor

Name: Elitechgroup Australia Pty Ltd

Manufacturer

Name: Kova International
Country: United States of America
Address: 7272 Chapman Avenue Suite B, Garden Grove, CA, 92841

Intended purpose

IVDs intended to be used as urine control for qualitative and semi-quantitative procedures used in petrochemical and chemical determinations and microscopic sediment analyses of human urine.

About this record

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Elitechgroup Australia Pty Ltd, manufactured by Kova International in United States of America. The device registration started on October 28, 2013.

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.