HBsAg Rapid Test Kits-Cassette-Based

Form: Cassette-Based Rapid Test Kits

Strength: sensitivity >95%, specificity >99%

Reference Brands: BinaxNOW, OraQuick, STANDARD Q, DPP® HIV/Syphilis Assay(US)

Category: Rapid Test Kits

Hepatitis B Surface Antigen (HBsAg) cassette-based rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality. 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 evaluations to meet stringent regulatory standards. Proper documentation includes safety profiles, clinical performance data, and manufacturing practices. For detailed licensing requirements, approved dossiers, and latest regulatory updates, visit Pharmatradz. Stay informed on the global approval landscape to ensure compliance and reliable hepatitis B screening solutions.