Australia TGA ARTG record

Clinical chemistry toxicology/drug detection IVDs

Australia TGA ARTG Registered Device · Siemens Healthcare Pty Ltd · ARK Diagnostics Inc · Class IIa · Started July 26, 2019

Good Name: Siemens Healthcare Pty Ltd - Clinical chemistry toxicology/drug detection IVDs

Device classification

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

Registration information

Start Date: July 26, 2019
Effective Date: July 26, 2019

Sponsor

Name: Siemens Healthcare Pty Ltd

Manufacturer

Name: ARK Diagnostics Inc
Country: United States of America
Address: 48089 Fremont Boulevard, Fremont, CA, 94538

Intended purpose

For in vitro diagnostic use in the quantitative and/or semi-quantitative and/or qualitative determination of toxic substances, pharmaceutical drugs and/or drugs of abuse in clinical specimens.

About this record

Access comprehensive regulatory information for Clinical chemistry toxicology/drug detection IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Siemens Healthcare Pty Ltd, manufactured by ARK Diagnostics Inc in United States of America. The device registration started on July 26, 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.