01 Major Regulatory Approval, Joining the Industry's First Echelon

Good News

We are thrilled to share groundbreaking news! The self-test kit for Helicobacter pylori antigen independently developed by the medical division of Linaxin Group has passed rigorous reviews by the National Medical Products Administration (NMPA) and obtained the National Class III Medical Device Registration Certificate. It enables the public to access the same precise screening available in Grade A tertiary hospitals from the comfort of home.

02 Class III Medical Device Qualification: The Gold Standard for Authorized At-Home Testing

Medical devices in China are subject to tiered supervision, with Class III representing the strictest regulatory category for in vitro diagnostic products. Approval standards are extremely stringent, requiring extensive clinical trials, full registration testing, multiple rounds of technical evaluation, and end-to-end production quality control audits. In contrast, ordinary disinfection products and Class II devices undergo looser approval procedures with limited clinical data; most lack legal qualification for home self-testing, and their results cannot serve as a basis for clinical diagnosis. This approval verifies that Linaxin's self-test product matches hospital-grade diagnostic reagents in compliance, accuracy and safety, with test results holding authoritative clinical reference value.

03 Addressing Pain Points of Traditional Testing, Ideal for Nationwide At-Home Screening

Statistics show that the Helicobacter pylori infection rate in China exceeds 50%. It is a primary trigger of halitosis, acid reflux, stomach pain and chronic gastritis, as well as a high-risk pathogenic factor for gastric conditions, making regular screening essential.

Conventional detection methods including C13/C14 breath tests and gastroscopy carry notable drawbacks: fasting requirements, long waiting queues, radiation exposure for certain tests, invasive discomfort from gastroscopy, and cumbersome follow-up recheck procedures. These barriers discourage many people from getting screened regularly.

Linaxin's hospital-grade Helicobacter pylori self-test kit has undergone comprehensive upgrades to fully meet demand for routine nationwide at-home screening, filling a gap in the market for accurate household diagnostic solutions.

04 Four Core Advantages for Safe Use by the Entire Family

√ Non-invasive and safe testing for all populations

Adopting stool antigen detection, the kit requires no fasting, no medication suspension, no blood draw, and produces zero radiation or bodily invasion. It is safe for seniors, children, women preparing for pregnancy and pregnant users. A dedicated sampling device ensures clean, contamination-free collection.

√ Intuitive operation with rapid results

User-friendly one-step operation accessible to anyone without prior training. Clear test results are available within 10–15 minutes, eliminating time wasted waiting in hospital lines.

√ Hospital-grade high precision with minimal false positive/negative results

Built on the high-specificity monoclonal antibody sandwich double assay recommended by clinical guidelines, the kit drastically reduces missed and incorrect detections, delivering diagnostic accuracy comparable to hospital laboratory equipment.

√ Suitable for routine whole-family screening

Individually sealed sterile single-use packs offer excellent cost performance. Ideal for routine family health checks, self-screening for gastric discomfort, and post-eradication efficacy follow-ups, covering all screening scenarios.

05 Backed by Robust Strength for Reliable Quality

1. Rare authoritative certification: Holding a Class III Medical Device Certificate, the highest qualification for home self-test products. Fully compliant with regulatory standards and traceable under NMPA oversight, eliminating risks associated with uncertified counterfeit goods;

2. Independent control of core technologies: In-house development and production of core biological raw materials and detection processes remove reliance on external technology, delivering stable and consistent testing accuracy;

3. Strict end-to-end quality control: Manufactured in standardized GMP production facilities complying with the ISO 13485 international medical quality management system. Every batch undergoes stringent inspection to guarantee stable, dependable quality.

06 Deep Cultivation in At-Home Medical Care to Safeguard National Gastrointestinal Health

Early screening and detection are pivotal to preventing gastrointestinal diseases. Today, certified hospital-grade Class III at-home diagnostic kits represent a new trend in national health consumption.

Moving forward, the medical division of Linaxin Group will continue to deepen its footprint in the at-home in vitro diagnostic sector. Persisting in independent technological innovation, we will launch more highly accurate, user-friendly and cost-effective hospital-grade home testing products, bringing professional diagnostic screening to every household and delivering comprehensive protection for the gastrointestinal health of all people.