ARTG 475206

General laboratoryware IVDs

ARTG ID: 475206 · Abacus dx Pty Ltd · SD Biosensor Inc · Class I · Started January 08, 2025

Good Name: Abacus dx Pty Ltd - General laboratoryware IVDs

Device classification

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

Registration information

ARTG ID: 475206
Start Date: January 08, 2025
Effective Date: January 08, 2025

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

The SD Biosensor calibration kits are designed to check the functionality of the optical systems in the STANDARD M10, STANDARD F200 Analyzer, and STANDARD F2400 Analyzer.

About this record

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 475206 and sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on January 08, 2025.

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.