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Ivd Reagent H. P. Rapid Test Strip/Cassette. CE, FDA, ISO13485 Certified: Product holds CE, FDA, and ISO13485 certifications for quality assurance. Sandwich Immunochromatographic Assay: Utilizes advanced sandwich solid phase immunochromatographic technology. High Accuracy Control Line: Red control line confirms correct performance and device functionality. Clear Visual Results: Distinct red lines indicate positive or negative H. pylori antigen presence. Multiple Format Options: Available in strips and cassettes for serum, plasma, whole blood, and feces. Global Market Availability: Exported to North America, Europe, Southeast Asia, Africa, and East Asia.