Hiv Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Serum or Plasma-Based Test Kits
Available Strengths: sensitivity and specificity.: 99-100%
Reference Brands: Bio-Rad HIV 1/2, Abbott Architect, Gallo HIV Combo(US)
Category: Rapid Test Kits
HIV Rapid Test Kits is available in Serum or Plasma-Based Test Kits and strengths such as sensitivity and specificity.: 99-100%. 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, HIV 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) |
HIV 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: HIV serum/plasma-based tests in the EU and US require strict regulatory approval. In the EU, these tests must comply with CE marking standards, ensuring safety and efficacy. In the US, FDA approval or Emergency Use Authorization (EUA) is mandatory. A comprehensive dossier, including clinical validation data, manufacturing details, and quality assurance, is essential for approval. Reliable test kits enhance early HIV detection, improving patient outcomes. For expert guidance on regulatory compliance and to access validated products, visit Pharmatradz. Ensuring adherence to these standards helps manufacturers succeed in global markets while maintaining high quality and safety standards.
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