Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits

Form: Lateral Flow Immunoassay (Dipstick)

Strength: sensitivity >95%, specificity >99%

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

Category: Rapid Test Kits

Hepatitis B Surface Antigen (HBsAg) rapid lateral flow immunoassay (dipstick) test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and quality in compliance with GMP and CE marking standards. In the US, FDA approval is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous clinical validation, stability testing, and manufacturing audits prior to approval. For detailed regulatory insights, licensing procedures, and approved dossiers, visit Pharmatradz. Staying informed on the latest regulatory updates ensures market compliance and reliable hepatitis B screening worldwide.