H. pylori Antigen Rapid Test Kit

Form: Cassette-based immunochromatographic test kits/Dipstick or strip formats

Strength: high sensitivity (>90%)

Reference Brands: Premier Platinum H. pylori, Schutz, Nova Test, Abnova H. pylori(US)

Category: Rapid Test Kits

H. pylori antigen rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality in compliance with GMP and IVDR standards. In the US, FDA approval is required, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. These kits undergo rigorous validation, clinical performance testing, and stability assessments. Proper documentation includes safety profiles, clinical performance data, and manufacturing details. For detailed licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid detection of active H. pylori infection, supporting effective diagnosis and treatment worldwide.