ARTG 470665Clinical chemistry hormone IVDs
ARTG ID: 470665 · 2San Pty Ltd · Hangzhou Alltest Biotech Co Ltd (China) · Class IIa · Started November 27, 2024
Good Name: 2San Pty Ltd - Clinical chemistry hormone IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 470665
- Start Date
- November 27, 2024
- Effective Date
- November 27, 2024
- Name
- 2San Pty Ltd
- Country
- China
- Address
- 550# Yinhai Street Hangzhou Economic and Technological Development Area, Hangzhou, 310018
2San Early Pregnancy hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream (Urine): The hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. This device is for single use in self-testing. 2San Peak Fertility LH Ovulation Rapid Test Midstream (Urine): The LH Ovulation Rapid Test Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of lutenizing hormone (LH) in urine to aid in the detection of ovulation. This device is for single use in self-testing. 2San FSH Rapid Test Midstream (Urine): The FSH Rapid Test Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine to aid in the detection of menopause. This device is for single use in self-testing.
Access comprehensive regulatory information for Clinical chemistry hormone IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 470665 and sponsored by 2San Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd (China) in China. The device registration started on November 27, 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.