Hiv 1/2 Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Lateral Flow Cassette Tests
Available Strengths: Detection limits typically 100–200 copies/mL of blood. & Sensitivity & Specificity: >98%
Reference Brands: OraQuick, Determine (Abbott), SD Bioline(EU & US)
Category: Rapid Test Kits
HIV 1/2 Rapid Test Kits is available in Lateral Flow Cassette Tests and strengths such as Detection limits typically 100–200 copies/mL of blood. & Sensitivity & Specificity: >98%. 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 1/2 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 1/2 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 Lateral Flow Cassette Tests require CE marking under IVDR in the EU and FDA 510(k) clearance in the US for legal market entry. EU regulations demand clinical performance evaluation, risk analysis, and QMS under ISO 13485. In the US, analytical and clinical performance data are vital for approval. A well-structured CTD dossier including stability, validation, and IFU ensures compliance and builds buyer trust. Pharmatradz provides regulatory-ready dossiers and sourcing support for HIV rapid test kits to ease your entry into regulated markets.
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