Australia TGA ARTG record

Clinical chemistry toxicology/drug detection IVDs

Australia TGA ARTG Registered Device · Specialty Diagnostix Pty Ltd · Biochemical Diagnostics Inc · Class IIa · Started January 06, 2017

Good Name: Specialty Diagnostix Pty Ltd - Clinical chemistry toxicology/drug detection IVDs

Device classification

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

Registration information

Start Date: January 06, 2017
Effective Date: January 06, 2017

Sponsor

Name: Specialty Diagnostix Pty Ltd

Manufacturer

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

Intended purpose

Materials used in IVDs for the 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 Specialty Diagnostix Pty Ltd, manufactured by Biochemical Diagnostics Inc in United States of America. The device registration started on January 06, 2017.

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.