Malaria (Pf/Pv) Rapid Test Kits bulk supplier for pharma manufacturers

Malaria (Pf/Pv) Rapid Test Kits Suppliers & Bulk Manufacturers

Available Forms: Cassette-based immunochromatographic tests/Test strip dipsticks

Available Strengths: 95% accuracy

Reference Brands: Access Bio CareStart, SD Biosensor, Fieldease, Abbott CareStart(US)

Category: Rapid Test Kits

Malaria (Pf/Pv) Rapid Test Kits is available in Cassette-based immunochromatographic tests/Test strip dipsticks and strengths such as 95% accuracy. 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, Malaria (Pf/Pv) 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)

Malaria (Pf/Pv) 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.

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Product Description:

Malaria (Pf/Pv) rapid test kits are approved in the US and EU, supported by dossiers demonstrating safety, high sensitivity, and specificity. In the US, FDA clearance is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, stability testing, and clinical performance evaluation to meet stringent standards. Proper documentation includes safety profiles, performance data, and manufacturing practices. For detailed licensing requirements, approved dossiers, and regulatory updates, visit Pharmatradz. Stay informed on the latest approval processes to ensure reliable malaria screening solutions for global health initiatives.

Frequently Asked Questions

Yes, Malaria (Pf/Pv) Rapid Test Kits is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Malaria (Pf/Pv) Rapid Test Kits is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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