Dengue Ns1 Antigen Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Cassette-based immunochromatographic tests/Dipstick tests
Available Strengths: high sensitivity (>90%) within the first 5 days of infection
Reference Brands: SD BIOLINE Dengue NS1, CareUS Dengue NS1, NovaTec Dengue NS1(US)
Category: Rapid Test Kits
Dengue NS1 Antigen Rapid Test Kits is available in Cassette-based immunochromatographic tests/Dipstick tests and strengths such as high sensitivity (>90%) within the first 5 days of infection. 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, Dengue NS1 Antigen Rapid 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) |
Dengue NS1 Antigen Rapid 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: Dengue NS1 Antigen Rapid Test Kits are approved in both the EU and US, supported by dossiers demonstrating safety, high sensitivity, and specificity in detecting early dengue infection. In the US, FDA approval is required, while in the EU, CE marking ensures compliance with IVDR regulations. These kits undergo rigorous validation, stability testing, clinical performance evaluation, and manufacturing audits to meet strict standards. Proper documentation includes safety profiles, performance data, and regulatory approvals. For detailed licensing, dossier requirements, and latest regulatory updates, visit Pharmatradz. Stay informed on global approval processes to ensure reliable, rapid dengue diagnosis for effective disease management.
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