Australia TGA ARTG recordClinical chemistry biological screening IVDs
Australia TGA ARTG Registered Device · Blackaby Diagnostics Pty Ltd · Biosynex SA · Class IIa · Started February 08, 2018
Good Name: Blackaby Diagnostics Pty Ltd - Clinical chemistry biological screening IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- February 08, 2018
- Effective Date
- February 08, 2018
- Name
- Biosynex SA
- Country
- France
- Address
- 12 rue Ettore Bugatti, Eckbolsheim-CS28006, F-67038 Strasbourg Cedex, CS28006
An in-hospital / in-laboratory immunochromatographic rapid test inclusive of cassette and buffer for the qualitative detection of human haemoglobin in human faecal specimens. This kit is intended for use as an aid in the diagnosis of lower gastrointestinal pathologies such as colorectal cancer and its previous stages.
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 Blackaby Diagnostics Pty Ltd, manufactured by Biosynex SA in France. The device registration started on February 08, 2018.
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.