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Clinical chemistry substrate IVDs - ARTG 469525

Access comprehensive regulatory information for Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 469525 and sponsored by Ical & Trading Co, manufactured by Sejoy Biomedical Co Ltd in China. The device registration started on November 20, 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 469525
Class IIa
Clinical chemistry substrate IVDs
ARTG ID: 469525
Good Name: Ical & Trading Co - Clinical chemistry substrate IVDs
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Intended Purpose

The Lipid Panel Monitoring System is composed of the Lipid Panel Meter and Lipid Panel Test Cartridges. The Lipid Panel Monitoring System is intended for quantitatively measuring the concentration of Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL) and Triglyceride (TG) with capillary whole blood sample or venous whole blood. The system is intended for professional use. It is used for in-vitro diagnostic use only.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
469525
Start Date
November 20, 2024
Effective Date
November 20, 2024
Manufacturer
Country
China
Address
Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100