Australia TGA ARTG record

Clinical chemistry toxicology/drug detection IVDs

Australia TGA ARTG Registered Device · Thermo Fisher Scientific Australia Pty Ltd · Biochemical Diagnostics Inc · Class IIa · Started April 06, 2021

Good Name: Thermo Fisher Scientific Australia Pty Ltd - Clinical chemistry toxicology/drug detection IVDs

Device classification

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

Registration information

Start Date: April 06, 2021
Effective Date: April 06, 2021

Sponsor

Name: Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Name: Biochemical Diagnostics Inc
Country: United States of America
Address: 180 Heartland Blvd, Edgewood, NY, 11717

Intended purpose

An In Vitro Diagnostic device intended for use as quality control to monitor the precision of laboratory urine and/or oral fluid toxicology testing procedures for a range of analytes.

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 Thermo Fisher Scientific Australia Pty Ltd, manufactured by Biochemical Diagnostics Inc in United States of America. The device registration started on April 06, 2021.

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.