COVID-19 Rapid Antigen Test Kits

Form: Lateral Flow Assay (LFA) Devices

Strength: 85-97%, with detection of high viral loads

Reference Brands: Flowflex, iHealth(US)

Category: Rapid Test Kits

COVID-19 rapid antigen test kits, based on lateral flow assay (LFA) devices, are regulated as in vitro diagnostic (IVD) medical devices in the US by the FDA and in the EU via EMA. Approval requires dossiers including clinical performance, safety data, manufacturing standards, and quality controls. The FDA reviews clinical trial and validation data for timely emergency use authorization or full approval, while the EMA ensures compliance with regional safety standards. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe use, and broad global availability, enabling rapid COVID-19 screening assistance in healthcare and at-home settings worldwide.