Dengue IgG/IgM Rapid Test Kits

Form: Cassette-based immunochromatographic tests/Dipstick or strip tests

Strength: high sensitivity (>90%)

Reference Brands: Alba Biotech, Access Bio CareUS, NovaTec, SD Biosensor, Chembio(US)

Category: Rapid Test Kits

Dengue IgG/IgM Rapid Test Kits are approved for use in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and reliability. In the US, FDA clearance is essential, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, clinical performance testing, stability assessments, and manufacturing audits to meet strict standards. Proper documentation includes safety profiles, performance data, and certification details. For comprehensive licensing, approved dossiers, and latest regulatory updates, visit Pharmatradz. Stay informed on global approval processes to ensure deployment of effective dengue diagnostic solutions worldwide.