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General laboratory reagent and consumables IVDs - ARTG 338313

Access comprehensive regulatory information for General laboratory reagent and consumables IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 338313 and sponsored by Equinox Medical Pty Ltd, manufactured by 3D Biomedicine Science & Technology Co Ltd in China. The device registration started on June 24, 2020.

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 338313
Class IIa
General laboratory reagent and consumables IVDs
ARTG ID: 338313
Good Name: Equinox Medical Pty Ltd - General laboratory reagent and consumables IVDs
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DJ Fang

DJ Fang

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Intended Purpose

The 3DMed extraction and purification kits are designed for the rapid extraction and purification of nucleic acids from clinical specimens using magnetic bead-based technology. Purified nucleic acids can be directly used for downstream applications such as RT-qPCR. The kits are optimized for automated nucleic acid extraction and purification with the ANDiS Automated Nucleic Acids Extraction Systems.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
338313
Start Date
June 24, 2020
Effective Date
June 24, 2020
Manufacturer
Country
China
Address
Room 304 404 402 401 Building 2 No 158 Xinjunhuan St, Minhang District, Shanghai, 201114