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Instrument/analyser IVDs - ARTG 301214

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 301214 and sponsored by Abacus dx Pty Ltd, manufactured by Dynex Technologies Inc in United States of America. The device registration started on March 23, 2018.

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 I
ARTG 301214
Class I
Instrument/analyser IVDs
ARTG ID: 301214
Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

ELISA processor for analysis in critical applications including immunology, infectious disease, hormone, allergy and blood-chemistry

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
301214
Start Date
March 23, 2018
Effective Date
March 23, 2018
Manufacturer
Country
United States of America
Address
14340 Sullyfield Circle, Chantilly, VA, 20151