LYHER H.pylori Antigen Test Kit Obtained Product Certification in Ecuador

On November 9, 2024, LYHER H.pylori Antigen Test Kit has successfully certified by Ecuador ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria), the medical device regulatory authority in Ecuador, which means this product has obtained market access permission to Ecuador.

LYHER H.pylori Antigen Test Kit uses in vitro qualitative detection of Helicobacter pylori (Hp) antigen in human stool samples to assist in screening for the presence of Helicobacter pylori infection. Hp is a type of bacteria that can colonize on the surface of gastric mucosal epithelial cells. As the cells are renewed and shed, Hp will also be excreted. By detecting the antigen in the stool, we can know whether an individual is infected with Hp. This kit has the following advantages:

1. · Quick results: shorten waiting time and improve diagnostic efficiency.
2. · Easy to read test results: clear and intuitive, allowing medical personnel to make quick judgments.
3. · Reliable results: the accuracy rate exceeds 99%, ensuring the accuracy of diagnosis.

The kit is suitable for use in a variety of professional usage scenarios such as hospitals, laboratories, clinics and medical centers. It provides an effective screening and diagnosis method for Helicobacter pylori infection and helps early treatment of patients.

The certification obtained by ARCSA in Ecuador marks the first time that LYHER's H.pylori antigen test product has obtained a product registration certificate in South America, following the China NMPA and the EU CE certification. This signifies that this product can be legally imported and sold in Ecuador, further accelerating the company's expansion into the global market.