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Malaria (Pf/Pv) Rapid Test Kits

Form: Cassette-based immunochromatographic tests/Test strip dipsticks

Strength: 95% accuracy

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

Category: Rapid Test Kits

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.

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