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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 Specialty Diagnostix Pty Ltd, manufactured by Kova International in United States of America. The device registration started on July 19, 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: Specialty Diagnostix Pty Ltd - Clinical chemistry biological screening IVDs
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Intended Purpose

Intended for use in the clinical laboratory as a control for qualitative and semi quantitative procedures used in urinalysis.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
July 19, 2018
Effective Date
July 19, 2018
Manufacturer
Country
United States of America
Address
7272 Chapman Avenue Suite B, Garden Grove, CA, 92841