Australia TGA ARTG recordInstrument/analyser IVDs
Australia TGA ARTG Registered Device · Biocelect Pty Ltd · SD Biosensor Inc · Class I · Started April 21, 2021
Good Name: Biocelect Pty Ltd - Instrument/analyser IVDs
- Risk Class
- Class I
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- April 21, 2021
- Effective Date
- April 21, 2021
- Name
- SD Biosensor Inc
- Country
- South Korea
- Address
- C-4th & 5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690
The STANDARD G6PD Analyzer is designed to measure the semi-quantitative determination of total-hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimen based on reflectometry assays. The test is intended to aid in the identification of people with G6PD deficiency providing point-of care access and allowing prompt treatment decisions. The analyzer is for in vitro diagnostic use and professional use only.
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 Biocelect Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on April 21, 2021.
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.