Covid-19 Rapid Antigen Test Kits Suppliers & Bulk Manufacturers
Available Forms: Lateral Flow Assay (LFA) Devices
Available Strengths: 85-97%, with detection of high viral loads
Reference Brands: Flowflex, iHealth(US)
Category: Rapid Test Kits
COVID-19 Rapid Antigen Test Kits is available in Lateral Flow Assay (LFA) Devices 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 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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: 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.
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