COVID-19 Rapid Antigen Test Kits
Form: Swab Collection Kits
Strength: 85-97%, with detection of high viral loads
Reference Brands: BinaxNOW(US)
Category: Rapid Test Kits
BinaxNOW, an FDA Emergency Use Authorization (EUA) for COVID-19 rapid antigen testing, is regulated as an in vitro diagnostic (IVD) device in the US, while in the EU, it is regulated by CE marking and regional authorities. Approval requires dossiers including clinical performance, safety, manufacturing, and quality data. The FDA reviews validation studies and real-world performance for swift EUA approval or full marketing authorization, while the EMA ensures compliance with safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance supports timely approval, safe use, and global distribution, aiding rapid COVID-19 screening worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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