Australia flagARTG 443112

Clinical chemistry vitamin and mineral IVDs

ARTG ID: 443112 · Aceso Diagnostics Pty Ltd · Hangzhou Alltest Biotech Co Ltd · Class IIa · Started March 04, 2024

Good Name: Aceso Diagnostics Pty Ltd - Clinical chemistry vitamin and mineral IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
443112
Start Date
March 04, 2024
Effective Date
June 18, 2024
Sponsor
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou, 310018
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.

About this record

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 443112 and sponsored by Aceso Diagnostics Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on March 04, 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.

Free DatabasePowered by Pure Global AITGA ARTG Official Data