Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Abacus dx Pty Ltd · SD Biosensor Inc · Class I · Started July 01, 2024

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

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: July 01, 2024
Effective Date: July 01, 2024

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: SD Biosensor Inc
Country: South Korea
Address: C-4th & 5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690

Intended purpose

IVD analyzers for measuring quantitative or qualitative biomarkers in body fluids such as blood, urine, and nasal mucus in laboratory and point-of-care settings by healthcare professionals only. The analyzers should be used with the specified test device or cartridge manufactured by SD BIOSENSOR Inc, as described in the package insert instructions of that specific test.

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 sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on July 01, 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.