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Instrument/analyser IVDs - ARTG 463879

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 463879 and sponsored by Abacus dx Pty Ltd, manufactured by Response Biomedical Corporation in Canada. The device registration started on October 08, 2024.

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 463879
Class I
Instrument/analyser IVDs
ARTG ID: 463879
Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

The RAMPยฎ 200 is an in vitro diagnostic medical device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. It is an automated device intended to be used by professional users in a clinical laboratory setting.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
463879
Start Date
October 08, 2024
Effective Date
October 08, 2024
Manufacturer
Country
Canada
Address
1781 75th Avenue West, Vancouver, British Col, V6P 6P2