HIV 1/2 Rapid Test Kits
Form: (Lateral Flow Cassette Tests)
Strength: 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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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