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Microbial-isolate identification and testing IVDs

Access comprehensive regulatory information for Microbial-isolate identification and testing 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 Mast Group Ltd in United Kingdom. The device registration started on February 21, 2020.

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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TGA ARTG Official Data
Class IIa
Class IIa
Microbial-isolate identification and testing IVDs
Australia TGA ARTG Registered Device
Good Name: Blackaby Diagnostics Pty Ltd - Microbial-isolate identification and testing IVDs
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Intended Purpose

Intended to be used in testing to provide information about the specific in vitro characteristics and/or identification of bacterial microorganisms that have been isolated from a clinical specimen.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 21, 2020
Effective Date
February 21, 2020
Manufacturer
Country
United Kingdom
Address
Mast House Derby Road, Bootle, L20 1EA