Australia TGA ARTG record

Clinical chemistry biological screening IVDs

Australia TGA ARTG Registered Device · 2San Pty Ltd · Hangzhou Alltest Biotech Co Ltd (China) · Class IIa · Started April 10, 2024

Good Name: 2San Pty Ltd - Clinical chemistry biological screening IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: April 10, 2024
Effective Date: April 10, 2024

Sponsor

Name: 2San Pty Ltd

Manufacturer

Name: Hangzhou Alltest Biotech Co Ltd (China)
Country: China
Address: 550# Yinhai Street Hangzhou Economic and Technological Development Area, Hangzhou, 310018

Intended purpose

Vaginal PH:The Vaginal pH Rapid Test Panel (Vaginal Swab) is a rapid dry chemical method for the semi-quantitative detection of pH in female vaginal swab specimens to aid in the diagnosis of bacterial vaginosis. UTI: The Urinary Tract Infections Test (Urine) compromises firm plastic strips onto which several separate reagents are affixed. The test is for the qualitative detection following analytes in urine: Leukocytes, Blood, Nitrite and Protein. The Urinary Tract Infections Test (Urine) is for single use in self-testing.

About this record

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 sponsored by 2San Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd (China) in China. The device registration started on April 10, 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.