Hepatitis C Antibody Rapid Test Kits

Form: Cassette-based lateral flow immunoassays/Test strip dipsticks

Strength: >98% sensitivity and specificity

Reference Brands: OraQuick, Bio-Rad, Chembio, SD Biosensor, Premier(US)

Category: Rapid Test Kits

Hepatitis C antibody rapid test kits are approved in both the US and EU, supported by dossiers demonstrating safety, high sensitivity, and specificity. In the US, FDA clearance is mandatory, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, stability testing, and clinical evaluation to meet stringent regulatory 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 the deployment of reliable hepatitis C screening solutions globally.