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Clinical chemistry biological screening IVDs - ARTG 442010

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 442010 and sponsored by Clifford Hallam Healthcare Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on February 22, 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 442010
Class IIa
Clinical chemistry biological screening IVDs
ARTG ID: 442010
Good Name: Clifford Hallam Healthcare Pty Ltd - Clinical chemistry biological screening IVDs
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Intended Purpose

The Urinary Tract Infections Rapid Test (Urine) is firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative detection of the following analytes in human urine: Blood, Protein, Nitrite and Leukocytes. The Urinary Tract Infections Rapid Test (Urine) is for single use in self-testing.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
442010
Start Date
February 22, 2024
Effective Date
February 26, 2024
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou, 310018