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Clinical chemistry toxicology/drug detection IVDs - ARTG 284250

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 registered under ARTG number 284250 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 284250
Class IIa
Clinical chemistry toxicology/drug detection IVDs
ARTG ID: 284250
Good Name: Specialty Diagnostix Pty Ltd - Clinical chemistry toxicology/drug detection IVDs
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Intended Purpose

Materials used in IVDs for the determination of toxic substances, pharmaceutical drugs and or drugs of abuse in clinical specimens.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
284250
Start Date
January 06, 2017
Effective Date
January 06, 2017
Manufacturer
Country
United States of America
Address
180 Heartland Blvd, Edgewood, NY, 11717