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Clinical chemistry hormone IVDs - ARTG 317593

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 317593 and sponsored by Fertility2Family, manufactured by Nantong Egens Biotechnology Co Ltd in China. The device registration started on May 15, 2019.

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 317593
Class IIa
Clinical chemistry hormone IVDs
ARTG ID: 317593
Good Name: Fertility2Family - Clinical chemistry hormone IVDs
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Intended Purpose

The One Step HCG Urine Pregnancy Test strip is a test kit for the determination of hCG (Human Chorionic Gonadotropin)in urine specimens. This test kit is used to obtain a visual qualitative result for early detection of pregnancy. The Ovulation LH Test strip is a qualitative test that can predict when there is a LH (luteinizing hormone) surge, and in turn, when you are likely to ovulate. Both of the tests are self-testing strips and easy to use.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
317593
Start Date
May 15, 2019
Effective Date
May 15, 2019
Sponsor
Manufacturer
Country
China
Address
Block A No15 Building No1692 Xinghu Ave Nantong Economy & Tech Development Zone, 226010