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General laboratoryware IVDs - ARTG 245294

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 245294 and sponsored by Key Diagnostics Pty Ltd, manufactured by Hardy Diagnostics in United States of America. The device registration started on July 01, 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.

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Class I
ARTG 245294
Class I
General laboratoryware IVDs
ARTG ID: 245294
Good Name: Key Diagnostics Pty Ltd - General laboratoryware IVDs
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Intended Purpose

CT1261 Microbial Isolate Identification and Testing IVDs. These are general culture confirmation tests for microbiology testing based upon chemical reactions such as indole, oxidase and carbohydrate utilisation.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
245294
Start Date
July 01, 2015
Effective Date
July 01, 2015
Manufacturer
Country
United States of America
Address
1430 West McCoy Lane, Santa Maria, CA, 93455