Australia TGA ARTG record

Clinical chemistry biological screening IVDs

Australia TGA ARTG Registered Device · Asquith Diagnostics Pty Ltd · Biosynex SA · Class IIa · Started November 26, 2015

Good Name: Asquith Diagnostics Pty Ltd - Clinical chemistry biological screening IVDs

Device classification

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

Registration information

Start Date: November 26, 2015
Effective Date: November 26, 2015

Sponsor

Name: Asquith Diagnostics Pty Ltd

Manufacturer

Name: Biosynex SA
Country: France
Address: 22 Boulevard Sebastien Brant, Illkirch-Graffenstaden, 67400

Intended purpose

This Fecal Occult Blood Device Test is a rapid, visual immuno-chromatographic test for the qualitative detection of human blood hemoglobin in faecal samples.

About this record

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Asquith Diagnostics Pty Ltd, manufactured by Biosynex SA in France. The device registration started on November 26, 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.