Hbsag Rapid Test Kits-Cassette-Based Suppliers & Bulk Manufacturers
Available Forms: Cassette-Based Rapid Test Kits
Available Strengths: sensitivity >95%, specificity >99%
Reference Brands: BinaxNOW, OraQuick, STANDARD Q, DPP® HIV/Syphilis Assay(US)
Category: Rapid Test Kits
HBsAg Rapid Test Kits-Cassette-Based is available in Cassette-Based Rapid Test Kits and strengths such as sensitivity >95%, specificity >99%. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, HBsAg Rapid Test Kits-Cassette-Based is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
HBsAg Rapid Test Kits-Cassette-Based can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: 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.
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