ARTG 463879

Instrument/analyser IVDs

ARTG ID: 463879 · Abacus dx Pty Ltd · Response Biomedical Corporation · Class I · Started October 08, 2024

Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs

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

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: Response Biomedical Corporation
Country: Canada
Address: 1781 75th Avenue West, Vancouver, British Col, V6P 6P2

Intended purpose

The RAMP® 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.

About this record

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.