Australia TGA ARTG record

Clinical chemistry therapeutic drug monitoring IVDs

Australia TGA ARTG Registered Device · Specialty Diagnostix Pty Ltd · ARK Diagnostics Inc · Class IIa · Started December 02, 2011

Good Name: Specialty Diagnostix Pty Ltd - Clinical chemistry therapeutic drug monitoring IVDs

Device classification

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

Registration information

Start Date: December 02, 2011
Effective Date: December 02, 2011

Sponsor

Name: Specialty Diagnostix Pty Ltd

Manufacturer

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

Intended purpose

IVDs that are intended to be used in monitoring of therapeutic drug levels in a clinical specimen.

About this record

Access comprehensive regulatory information for Clinical chemistry therapeutic drug monitoring IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Specialty Diagnostix Pty Ltd, manufactured by ARK Diagnostics Inc in United States of America. The device registration started on December 02, 2011.

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.