Australia flagARTG 265412

Clinical chemistry trace element IVDs

ARTG ID: 265412 · Abacus dx Pty Ltd · Sero AS · Class IIa · Started December 03, 2015

Good Name: Abacus dx Pty Ltd - Clinical chemistry trace element IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
265412
Start Date
December 03, 2015
Effective Date
December 03, 2015
Sponsor
Manufacturer
Country
Norway
Address
Stasjonsveien 44, Billingstad, N-1375
Intended purpose

IVDs intended to be used for the qualitative and/or quantitative determination of clinical chemistry trace elements in a clinical specimen.

About this record

Access comprehensive regulatory information for Clinical chemistry trace element IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 265412 and sponsored by Abacus dx Pty Ltd, manufactured by Sero AS in Norway. The device registration started on December 03, 2015.

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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