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Clinical chemistry biological screening IVDs

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.

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Class IIa
Class IIa
Clinical chemistry biological screening IVDs
Australia TGA ARTG Registered Device
Good Name: Blackaby Diagnostics Pty Ltd - Clinical chemistry biological screening IVDs
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 08, 2018
Effective Date
February 08, 2018
Manufacturer
Country
France
Address
12 rue Ettore Bugatti, Eckbolsheim-CS28006, F-67038 Strasbourg Cedex, CS28006