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Clinical chemistry vitamin and mineral IVDs - ARTG 453185

Access comprehensive regulatory information for Clinical chemistry vitamin and mineral IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 453185 and sponsored by 2San Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd (China) in China. The device registration started on June 21, 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 453185
Class IIa
Clinical chemistry vitamin and mineral IVDs
ARTG ID: 453185
Good Name: 2San Pty Ltd - Clinical chemistry vitamin and mineral IVDs
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DJ Fang

DJ Fang

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Intended Purpose

The Vitamin D Rapid Test Cassette is a rapid chromatographic immunoassay for the semi-quantitative detection of 25-hydroxyvitamin D (25(OH)D) in human fingerstick Whole blood. This assay provides a preliminary diagnostic test result and can be used to screen for Vitamin D deficiency. For self-testing in vitro diagnostic use only.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
453185
Start Date
June 21, 2024
Effective Date
June 21, 2024
Sponsor
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic and Technological Development Area, Hangzhou, 310018