Rapid gastrointestinal infection test Hepy Urease Test ®

ureaseHelicobacter pylorilaboratory

Overview
Design and manufacture of certified point-of-care medical devices for intra-procedural detection of Helicobacter pylori during endoscopy. Devices are developed for professional use in clinical endoscopy settings.

Clinical application
The test is intended to detect Helicobacter pylori in gastric or duodenal biopsy specimens collected during endoscopic procedures. For professional use only.

Key features

• Rapid diagnostics: Result available during the procedure; from 1 minute; designed for endoscopy; no laboratory equipment required.
• Dry test format: Ready-to-use; no liquids, gels or water required.
• Visual readout: Clear color reaction enabling immediate in-clinic interpretation.
• Transport stability: Suitable for a wide temperature range during transport; no cold chain required.
• Long shelf life: Four-year product stability to support storage and inventory planning.
• EU manufacturing and compliance: Produced in the European Union under an EN ISO 13485:2016 certified Quality Management System.

Standards & quality
Design, development, production and distribution are performed within a certified Quality Management System compliant with EN ISO 13485:2016. Quality oversight covers the full medical device lifecycle.

Intended use and procedure
Standardized procedure enabling result acquisition directly during endoscopic examination without additional diagnostic equipment. Point-of-care medical device for detection of Helicobacter pylori infection from biopsy specimens.

Specifications / technical data

• Intended use: Detection of Helicobacter pylori in gastric or duodenal biopsy specimens obtained during endoscopy (professional use).
• Test format: Dry, ready-to-use urease test (point-of-care).
• Sample type: Biopsy specimens from stomach or duodenum.
• Time to result: From 1 minute; result available during procedure.
• Readout: Visual color change for immediate interpretation.
• Laboratory requirements: No laboratory required; for in-clinic use.
• Stability & storage: Wide transport temperature range; no cold chain required; four-year shelf life.
• Manufacturing & compliance: EU manufacturing; EN ISO 13485:2016 certified Quality Management System.