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Clinical chemistry biological screening IVDs - ARTG 459007

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 registered under ARTG number 459007 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Kova International in United States of America. The device registration started on August 09, 2024.

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
ARTG 459007
Class IIa
Clinical chemistry biological screening IVDs
ARTG ID: 459007
Good Name: Siemens Healthcare Pty Ltd - Clinical chemistry biological screening IVDs
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Intended Purpose

In vitro diagnostic use as a control for qualitative and/or semi-quantitative procedures used in screening of human urine.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
459007
Start Date
August 09, 2024
Effective Date
August 09, 2024
Manufacturer
Country
United States of America
Address
7272 Chapman Avenue Suite B, Garden Grove, CA, 92841