Dengue NS1 Antigen Rapid Test Kits

Form: Cassette-based immunochromatographic tests/Dipstick tests

Strength: high sensitivity (>90%) within the first 5 days of infection

Reference Brands: SD BIOLINE Dengue NS1, CareUS Dengue NS1, NovaTec Dengue NS1(US)

Category: Rapid Test Kits

Dengue NS1 Antigen Rapid Test Kits are approved in both the EU and US, supported by dossiers demonstrating safety, high sensitivity, and specificity in detecting early dengue infection. In the US, FDA approval is required, while in the EU, CE marking ensures compliance with IVDR regulations. These kits undergo rigorous validation, stability testing, clinical performance evaluation, and manufacturing audits to meet strict standards. Proper documentation includes safety profiles, performance data, and regulatory approvals. For detailed licensing, dossier requirements, and latest regulatory updates, visit Pharmatradz. Stay informed on global approval processes to ensure reliable, rapid dengue diagnosis for effective disease management.