H. pylori Antibody Rapid Test Kits

Form: Cassette-based immunoassay (lateral flow)/Dipstick or strip formats

Strength: high sensitivity (>90%),

Reference Brands: SD Bioline H. pylori, Premier™ H. pylori, CareStart H. pylori Premier™ H. pylori, CareStart H. pylori(US)

Category: Rapid Test Kits

H. pylori antibody rapid test kits are approved in the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality. In the US, FDA clearance is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, performance testing, stability assessments, and quality audits. Proper documentation includes safety profiles, clinical efficacy data, and certification details. For comprehensive licensing guidance, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Staying informed ensures reliable, efficient H. pylori screening solutions for clinical use and public health management worldwide.