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
BinaxNOW is a rapid antigen test that detects specific viral proteins in nasal swabs. It provides quick results within 15-30 minutes, supporting prompt COVID-19 screening. Benefits include ease of use, quick turnaround, early detection, reduced transmission risk, and widespread accessibility for home and healthcare settings worldwide.
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.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
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.
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