Rotavirus Rapid Test Kits

Form: Lateral flow immunoassay/Dipstick or strip formats

Strength: High sensitivity (>90%) and specificity

Reference Brands: SD Bioline Rotavirus, Quidel QuickVue Rotavirus, Bio-Rad, Premier(US)

Category: Rapid Test Kits

Rotavirus rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing standards in accordance with GMP and IVDR regulations. In the US, FDA clearance ensures performance and safety, while in the EU, CE marking certifies compliance with in vitro diagnostic requirements. These kits undergo rigorous validation, clinical performance testing, stability assessments, and quality audits. Proper documentation includes safety profiles, performance data, and certification details. For detailed licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid detection of rotavirus infections to support effective disease management worldwide.