Covid-19 Rapid Antigen Test Kits- Swab Collection Suppliers & Bulk Manufacturers

Available Forms: Swab Collection Kits

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

Reference Brands: BinaxNOW(US)

Category: Rapid Test Kits

COVID-19 Rapid Antigen Test Kits- Swab collection is available in Swab Collection Kits and strengths such as 85-97%, with detection of high viral loads. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, COVID-19 Rapid Antigen Test Kits- Swab collection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

COVID-19 Rapid Antigen Test Kits- Swab collection can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description:

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.