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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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